Delivers excellence in end-to-end process improvement practices, methodologies, and behaviors to achieve transversally operational and support services areas’ efficiencies. Supports the continuous improvement cycle aiming at the sustainable increase of unitary output (effective throughput per resource unit used). Participation in the development, deployment, and maintenance of the most adequate methodologies and workflows, looking at maximization of workforce efficiency and adoption of the appropriate behaviors to enable engagement; as well as for deriving metrics to measure plant and equipment capacity to support identification of equipment and process flow bottlenecks, contributing to improved layouts whilst assuring compliance with established guidelines.
- Develop and apply knowledge of process optimization and participate in area processes, procedures optimization projects with the guidance of more senior colleagues
- Take part in Continuous Improvement Initiatives, problem solving and risk assessment groups
- Ensure that all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Create shift detailed schedule (short & mid-term) for the whole portfolio to answer demand, having into account production and support areas constraints (Quality Control, Warehouse, etc.)
- Review and analyze the allocated resources (human resources, materials and/or processes) to comply with plan
- Optimize the plan, ensuring the existence of resources for the continuous production and maximizing efficiency
- Anticipate and monitor potential scheduling/planning and data management challenges, taking actions to mitigate risks; troubleshoots scheduling /planning / data problems; facilitates and actively contributes to Site scheduling meetings; communicate and align alternative scenarios with other areas as defined in Planning and Data policies
- Work in collaboration with Operational Excellence to drive consistency of recipes activities sequencing, standards/load factors definition and update;
- Monitor performance and apply action plans to improve result of KPI's related to Planning/Scheduling process, mainly: Plan Adherence, Campaign Lead Time Adherence, Batch Execution Adherence, Batch Finish Date Adherence, Shift Performance, BOM accuracy, Routing accuracy, Work Location accuracy, Master Data and Supporting Accuracy
- Create periodically reports detailing the status of critical activities of on-going projects and KPIs
- Make quality and timely decisions within the operations planning and data management tasks
- Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs.
- To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system.
- Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
- To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures.
- To maintain good hygiene and housekeeping within the laboratory.
- To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area.
- Comply with the high standards in the QC Laboratories.
- To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures.
- To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories.
- Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms.
- Assist with audits as required, following the instruction of QC Management.
- Undertake any additional tasks to support the laboratory activities as and when required.
- Seek out additional information when one feels that the available information is not enough.
- Follow all annual performance review requirements, including completion of the self-assessment.
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.
Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.
- Assure cGMP compliance before, during and after validation/qualification activities of systems/equipment and manufacturing processes by assuring that all necessary procedures are implemented and are being followed
- Assure that systems/processes/methods are qualified/validated according to their intended use and product requirements
- Promote the importance of high-quality levels and the importance of a continuous improvement culture in core company activities
- Support Quality and Operational areas, promoting a continuous improvement culture and compliant with the applicable regulations and approved procedures
- Participate in the alignment and harmonization of the Qualification and Validation procedures within all Hovione sites, as requested by Corporate function
- Contribute for the alignment of Qualification and Validation methodologies among Digital (Automation/IT), Engineering, Maintenance, Production Areas and Quality Control, when applicable, to benefit systems compliance
- Participate in Conceptual, Basic and Detailed Design Review for Projects of each Hovione Site, and major Projects at any Site for Corporate function, in order to assure GMP compliance with applicable Guidelines, Corporate Procedures and any specific Site requirements
- Provide input to Plan and/or establish Qualification and Validation requirements for each project within the Team
- Establishes the required qualification activities of new or changed systems and/or facilities within the change control process
- Prepare VMPs for Projects of each Site, collaborate in the VMP for major Projects and support Project’s execution at each site, for Corporate functions
- Approve (pre and pro execution) Qualification and Validation protocols as well as Final VMP Report (for major Projects) and other systems’ related documentation such as Periodic
- Review Reports, at Site level Participate in the management of Quality Systems key activities
- Prepare/review Quality Systems methodologies related to the area objectives and provide training for the sites
- Propose qualification/validation related procedures and documents to be followed
- Participates or support internal or external/customer audits and health authority inspections
- Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems under her / his responsibility
- Propose improvements to the area as appropriate and solve problems
- Make quality, safely and timely decisions within the Qualification and Validation tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.
- Assure cGMP compliance before, during and after validation/qualification activities of systems/equipment and manufacturing processes by assuring that all necessary procedures are implemented and are being followed
- Assure that systems/processes/methods are qualified/validated according to their intended use and product requirements
- Promote the importance of high-quality levels and the importance of a continuous improvement culture in core company activities
- Support Quality and Operational areas, promoting a continuous improvement culture and compliant with the applicable regulations and approved procedures
- Participate in the alignment and harmonization of the Qualification and Validation procedures within all Hovione sites, as requested by Corporate function
- Contribute for the alignment of Qualification and Validation methodologies among Digital (Automation/IT), Engineering, Maintenance, Production Areas and Quality Control, when applicable, to benefit systems compliance
- Participate in Conceptual, Basic and Detailed Design Review for Projects of each Hovione Site, and major Projects at any Site for Corporate function, in order to assure GMP compliance with applicable Guidelines, Corporate Procedures and any specific Site requirements
- Provide input to Plan and/or establish Qualification and Validation requirements for each project within the Team
- Establishes the required qualification activities of new or changed systems and/or facilities within the change control process
- Prepare VMPs for Projects of each Site, collaborate in the VMP for major Projects and support Project’s execution at each site, for Corporate functions
- Approve (pre and pro execution) Qualification and Validation protocols as well as Final VMP Report (for major Projects) and other systems’ related documentation such as Periodic
- Review Reports, at Site level Participate in the management of Quality Systems key activities
- Prepare/review Quality Systems methodologies related to the area objectives and provide training for the sites
- Propose qualification/validation related procedures and documents to be followed
- Participates or support internal or external/customer audits and health authority inspections
- Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems under her / his responsibility
- Propose improvements to the area as appropriate and solve problems
- Make quality, safely and timely decisions within the Qualification and Validation tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
Performs maintenance on equipment and systems (e.g., mechanical, electrical). Evaluates and recommends equipment improvements to increase reliability, capability and yield. Performs equipment condition analysis (during preventive and unscheduled maintenance). Troubleshoots and diagnoses equipment problems / failures. Prepares technical reports to document equipment modifications and equipment maintenance procedures.
- Participate in the day to day preventative and corrective tasks (mechanical / electrical / instrumentation) in-line with the planned asset lifecycle management instructions
- Maintain, service, repair and troubleshoot all equipment and installations (mechanical / electrical / instrumentation) on site as per Standard Operating
- Procedures, maintenance work instructions or engineering best practices
- Ensure that equipment and infrastructures are maintained within their safe design operating limits, and in a way that avoids danger to personnel or the public
- Ensure the correct completion of all required documentation, paper or system based, associated with own work
- Participate in the implementation of continuous improvement initiative and lean tools within the area (TOP meetings, TPM, 5S, SMED, 8D)
- Participate in the Quality Assurance and HSE programs, guaranteeing the timely implementation of corrective actions (CAPA)
- Ensure proper tidiness and cleanliness of the maintained equipment and area as well as his/her working space
- Ensure that area or his/her assign tools are kept in good shape in what regards to their functionality and cleanliness
- Participate in programs and initiatives required to ensure plant cleanliness
- Follow procedures with clear instructions; seeks clarification if they are not clear
- Work follows an established pattern, with a requirement to run standard procedures, analysis, reports or tests
- Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes
- Suggest and participate in improvements in the area in which the TM is assigned
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Ensure facility activities are carried out in compliance with all GMP, legal and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practices
- Undertake any additional tasks commensurate with the role as and when required
Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.
- Manage projects in the allocated area and escalate complex issues to more senior colleagues or managers. It is recognized that the level of support required will increase when projects that are more complex are assigned. Project assignment will always be based on business need, however, preferentially, projects assigned will have a low to medium degree of complexity including:
- a low to medium cumulative sales / project cost value
- a low to medium to high project control level
- up to a medium customer segmentation level
- Proactively manage and take responsibility of the scope, cost, time and quality of each project assigned
- Deliver the project objectives (e.g. results, processes, products) through a structured approach in alignment with industry or Company best practices
- Lead the project team to take decisions or to decide to escalate the decision based on data
- Contribute to the project team composition and selection
- Clarify project team roles and responsibilities
- Communicate proactively and effectively internally and externally
- Build and sustain motivation of the project TMs and positive dynamics within the project team
- Give timely and specific feedback to the project TMs regularly, both positive and constructive
- Keep up to date on the best PM practices, standards and methodology in use within the industry
- Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Propose improvements to the area as appropriate and solve problems
- Make quality and timely decisions within the project management tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- Comply with all applicable GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
Act as servant leaders developing, coaching and supporting team members aligned with Hovione Supply Chain vision, mission and strategy. Promote cross-functional collaboration, effective communication and critical thinking to be able to improve rigor, discipline and predictability. Implement best practices and leverage on opportunities of standardization and harmonization between areas and sites based on continuous improvement and learning culture.
- Corporate function responsibilities include definition of best practices and standards in partnership with sites and areas
- Aligned with best practices and Corporate standards
-Guarantee the execution of the supply chain activities under responsibility (transportation, warehouse management, import/export, distribution and/or planning), with a long-term perspective and finding creative solutions
-Propose tactics to solve supply chain challenges, acting as a partner of production, maintenance, R&D and engineering
- Establish relationships with suppliers and customers to improve supply chain operations in terms of effectiveness, guaranteeing client satisfaction and timely delivery
-Oversee supply chain projects, giving direction and coordinating activities, in order to improve processes and systems
-Propose and guarantee the implementation of inventory targets and purchases of goods
-Create and implement supply chain metrics and KPIs ensuring its monitoring and control
-Define and guarantee the implementation of revisions on the supply chain methodologies and processes used, guaranteeing an increased efficiency (transportation, warehouse management, import/export, distribution and/or planning)
- Provide guidance in supply chain topics, keeping a good knowledge of processes, tools, legislation and methodologies (planning, scheduling, master data, warehouse management, import/export, transportation, distribution, etc.)
- Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
- Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with Supply Chain strategic objectives
- Monitor own´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures
- Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs
Promote one single source of truth, data highly reliable and up to date, best in class tools and practices to enhance productivity and the ability to manage costs. Facilitate cross-functional Sales and Operations Planning (S&OP, mid-term horizon) and Execution (short-term horizon) processes to create tensions and deliver best compromises in terms of supply response to demand forecast. Establish plans with appropriate granularity and firmness depending on horizons (mid, short-term horizons and execution), providing supply scenarios to demand, considering production and support areas capability and the best efficiency of resources' usage (people, equipment and materials), based on demonstrated performance.
- Create shift detailed schedule (30) / weekly plan (H90 & H700) for the whole portfolio to answer demand, having into account production and support areas constraints
- Review and analyze the allocated resources (human resources, materials and/or processes) to comply with plan
- Anticipate and monitor potential scheduling/planning and data management challenges, taking actions to mitigate risks; troubleshoots scheduling /planning / data problems; facilitates and actively contributes to H700H90 and H90H30 meetings; communicate and align alternative scenarios with other areas as defined in Planning and Data policies
- Optimize the plan, ensuring the existence of resources for the continuous production and maximizing efficiency
- Work in collaboration with Operational Excellence to drive consistency of recipes activities sequencing, standards/load factors definition and update;
- Monitor performance and apply action plans to improve result of KPI's related to Planning/Scheduling process, mainly: Plan Adherence, Campaign Lead Time Adherence, Batch Execution Adherence, Batch Finish Date Adherence, Shift Performance, BOM accuracy, Routing accuracy, Work Location accuracy, Master Data and Supporting Accuracy
- Create periodically reports detailing the status of critical activities of on-going projects and KPIs
- Promote one single source of truth, data highly reliable and up to date, best in class tools and practices
- Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Propose improvements to the area as appropriate and solve problems
- Make quality and timely decisions within the operations planning and data management tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
Coordinates inbound and outbound logistical operations being accountable for the imports and exports of goods and also information flows supporting these operations. Manages inventory, warehousing operations, regulate warehouse space, including reception, pathway, sampling, dispensing and arrange shipments, and local transportation to ensure an efficient supply of goods. Administers an effective system that meets the organization’s inventory targets through efficient and transparent flow of information and materials, including raw materials, intermediates, finished products and spare parts.
- Propose and implement complex logistics projects that have an impact on the efficiency and cost-effectiveness of the area (related with warehouse management, transportation, circuits and/or imports/exports)
- Implement complex processes and methodologies in logistics according to established guidelines (such as new regulations, legislation, policies and practices)
- Ensure that logistics policies are followed by the logistics teams, conducting controls, verifications and monitoring
- Prepare complex documentations related with logistics (such as warehouse management, transportation, circuits and/or imports/exports), analyzing and reviewing KPIs
- Communicate with external authorities, customers, suppliers in all relevant regions and countries to support logistics processes and solve complex problems
- Conduct complex analysis and reports related to logistics
- Optimize resources and procedures for continuous improvement
- Follow customer and authorities audits and inspections and guarantee the implementation of needed changes as requested
- Conduct investigation of events and propose corrective actions/preventive actions in logistics assuring the implementation on time of these actions
- Collaborate in the training of warehouse teams, proposing contents and delivering training sessions when required
- Keep a sound knowledge of current legislation and regulation in terms of logistics in the allocated regions
- Master logistics processes and tools (import/exports and/or warehouse management)
- Manage complex projects/ analysis with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
- Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures;
- Responsible for the accurately and timely preparation and review of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, and other GMP related documentation for all processes run in operations;
- Participate and ensure, with supervision, risk assessments for assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identified hazards are addressed prior to performing any operational activities;
- Report, investigate and document any potential risks, discrepancies, deviations and non-conformances in accordance with Hovione internal procedures;
- Timely devise and implement effective and efficient corrective actions / preventive actions (CAPAs), as appropriate;
- Report abnormal situations at the installations, as soon as these are detected, so that corrective maintenance is triggered in due time;
- Takes lead on non-complex projects / campaigns (with guidance) and supports the lead process engineer in complex projects / campaigns;
- Provide training on manufacturing processes to operational team members ensuring they are appropriately trained to perform the process related tasks;
- Initiate and prepare, with supervision, tech-transfers and process improvement projects for established processes utilizing best available technology, practices and tools;
- Contributes to the increase of productivity by reviewing and proposing the introduction of new technologies, methods and practices that have the opportunity to optimize the manufacturing processes.
Responsibilities
Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.
- Apply and develop knowledge of Quality’s Computerized Systems and participate in area processes, procedures and projects of computerized system developed in-house or off-the-shelf, with the guidance of more senior colleagues
- Support the evaluation of design documents against regulatory and Hovione compliance requirements as well as throughout its life cycle
- Apply a risk-based approach throughout the life cycle of the Computerized Systems taking into account patient safety, data integrity and product quality
- Understand and apply policies for Computerized Systems life cycle management
- Perform validation activities of the Computerized System projects and support teams to ensure compliance with Regulatory and Industry Standards throughout systems’ life cycle
- Participate as part of multi disciplinary work groups with Quality Assurance, Information Systems, User Areas and other Departments/Sites and contribute to the adequate and timely completion of all validation activities
- Collaborate in the definition of the required Qualification and Validation strategies for different Computerized Systems: Manufacturing equipment, DCS, PLC and other stand-alone software
- Issue/prepare/execute/review protocols and reports (i.e., DQ, IQ, OQ and PQ), relating to the Qualification of Computerized Systems and other validation/qualification documents
- Test all computerized systems to demonstrate its compliance with internal and external guidelines (such as 21CFR Part 11, GAMP, EU, PIC/s and ICH)
- Support in reviewing Computerized System change controls, deviations, incidents submitted by any Department/Site
- Support internal and external/ customers’ audits and health authorities’ inspections
- Run all assigned tasks on time, safely, efficiently, reliably and in a cost-effective manner
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
Implement, maintain and improve Process and Equipment Automation systems including user interfaces, data collection and OT-IT interfaces. Contributes and lead Industry 4.0 initiatives and foster the technological innovation facilitating the introduction and the evolution of Augmented Reality, Digital Twin, Assets Management, IoT and Data Analytics solutions. Supports OT systems and plant operations including maintenance, GMP/HSE compliance, Inspection& Audit support, user training and ensures solutions sustainability. Build data pipelines and applies ETL techniques to convey data from automation systems to informatics system and create specific applications for notifications and automatic reporting. Collect, analyze and report process data to support decision on day-to-day operations and for continuous improvement. Develop, implement and deploy optimization algorithms/models. Map business and operation processes, suggest changes to streamline procedures and automate repetitive tasks using RPA techniques. Develop robotics prototypes for specific applications and evaluate its scalability.
- Develop automation systems to control industrial processes, choosing and programming a controller and establishing communication between the sensors, the actuators and the controller
- Design, simulate, install, test and maintain electrical and mechanical automation of industrial processes
- Monitor automation processes on an ongoing basis, identifying and implementing improvements
- Implement code changes under change control
- Investigate and provide technical advice to support production, maintenance and other engineering disciplines related with operations
- Conduct and support automation data collection and reporting systems, network systems and automation system security
- Develop, customize and use data models and algorithms to improve operations, automation and business processes.
- Implement, maintain and improve Process and Equipment Automation systems including user interfaces, data collection and OT-IT interfaces
- Collect and analyze process data to support decision on day-to-day operations and for continuous improvement
- Build data pipelines and applies ETL techniques to convey data from automation systems to informatics system and create specific applications for notifications and automatic reporting
- Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Propose improvements to the area as appropriate and solve problems
- Make quality and timely decisions within the operational technologies and data tasks under her / his responsibility
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured;
- Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports;
- Prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary;
- Ensure inspection readiness in work completed and Act in an advisory capacity for all internal and external site audits;
- Periodic follow-up of ongoing deviations and Change Controls (PdAs) to assure timely closure of deviations and approval of PdAs, as appropriate;
- Prepares SOPs, department IOPs, quality related reports and change control documents (PdAs) as required and appropriate;
- Review process master documentation, revision of executed batch documentation and product specifications as required and appropriate;
- Review regulatory documentation and co-ordination of site documentation to support regulatory requirements;
- Authorize the usage of production equipment/utilities when qualification required.
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs.
- To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system.
- Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
- To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures.
- To maintain good hygiene and housekeeping within the laboratory.
- To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area.
- Comply with the high standards in the QC Laboratories.
- To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures.
- To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories.
- Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms.
- Assist with audits as required, following the instruction of QC Management.
- Undertake any additional tasks to support the laboratory activities as and when required.
- Seek out additional information when one feels that the available information is not enough.
- Follow all annual performance review requirements, including completion of the self-assessment.
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs.
- To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system.
- Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
- To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures.
- To maintain good hygiene and housekeeping within the laboratory.
- To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area.
- Comply with the high standards in the QC Laboratories.
- To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures.
- To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories.
- Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms.
- Assist with audits as required, following the instruction of QC Management.
- Undertake any additional tasks to support the laboratory activities as and when required.
- Seek out additional information when one feels that the available information is not enough.
- Follow all annual performance review requirements, including completion of the self-assessment.
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.
- Manage and coordinate a Team of Quality Assurance Specialists, dedicated to Spray Drying Projects and Products;
- Provide technical support and expertise to solve operational issues with the Team and Clients (both internal and external);
- Manage the cGMP programs (e.g. validation, qualification, stability, environmental control), within the scope of the Team.
- Assure that products are released according to its quality and timing requirements;
- Streamline a continuous improvement culture, mitigating any tendency for complexity;
- Conduct regular inspections of the operational areas to verify compliance with cGMPs (e.g Internal Audits);
- Represent the QA function in clients and regulatory audits or inspections;
- Manage and evaluate regularly data regarding the Key performance indicators established for the area;
- Approve, on quality’s behalf, IOPs, change control documents and process related documentation;
- Evaluate/approve equipment cleaning, qualification protocols and reports;
- Coordinate the Team in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all team members are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
Dedicated function focused on the development and implementation of the strategic plans and supporting initiatives necessary to realize the Corporate commitment to Sustainability. This function plays a key role in driving the changes needed for a sustainable future and acts to promote and monitor company performance in this area. Expected to have a high level of engagement with site and function leaders and promotes, motivates and supports an integrated company response on sustainability.
- Work with key internal stakeholders and/or external partners, driving alignment on sustainability project expectations.
- Serve as the point of contact for external ESG stakeholders, providing effective communication to team members, cross-functional stakeholders, and other relevant parties.
- Responsible for ESG client response & reporting including. program metrics and program benchmarks including annual reports and surveys.
- Support the implementation and integration of ESG internal standards in all supplier touchpoints (i.e., Code of Conduct, RFPs, Contract Templates)
- Work closely with business leaders to develop and embed ESG strategies into supply chain and ensures appropriate purchasing decisions are made with consideration of the ESG strategy.
- Assist in the development of short & long-term ESG project plans, key deliverables, and milestones and provide support in working through project changes or roadblocks that need to be resolved
- Support cross-functional teams in executing sustainability projects, monitoring and reporting on progress, and identifying necessary actions to achieve project goals.
- Where appropriate, provide thought leadership on sustainability best practices to progress the Hovione ESG/Sustainability agenda and support the development of key initiatives
- Provide support to monitor and evaluate external trends, including developing legislation and advocacy positions for insights to inform ongoing ESG strategy and practices.
- Role may support the completion of external sustainability reporting activities, social responsibility surveys and other aspects related to sustainable procurement
• Ensures master data integrity as well as maintaining the processes to support the data quality.
• Assure quality of master data development and documentation of processes with other functional data
owners to support ongoing maintenance.
• Identifies areas for data quality improvements and helps to resolve data quality problems through the
appropriate root cause analysis, process control the respective enhancement.
• Assists in data management, governance, and data quality of master data requirements with other
functional data owners to ensure functional master data integrity.
• Provide support in the application and implementation procedures of data standards and guidelines on
data ownership to ensure access to and integrity of data sets.
• Conducts data cleaning to rid the system of old, unused data, or duplicate data for better management and quicker access.
• Work in collaboration with Operational Excellence to drive consistency of recipes activities sequencing, standards/load factors definition and update.
• Monitor performance and apply action plans to improve result of KPI's related to BOM accuracy, Routing accuracy, Work Location accuracy, Master Data and Supporting Accuracy
• Create periodically reports detailing the status of critical activities of on-going projects and KPIs.
• Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner.
• Propose improvements to the area as appropriate and solve problems.
• Make quality and timely decisions within the operations planning and data management tasks under her / his responsibility
• Gather relevant data to inform the decision makers regarding complex issues
• Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.
- Fulfill and rigorously promote all applicable Good Manufacturing Practices (GMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities.
- Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures.
- Responsible for the accurately and timely preparation and review of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, cost proposals, validation plans and validation reports and other GMP related documentation for all processes run in operations.
- Execute and ensure, with autonomy, risk assessments for assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identified hazards are addressed prior to performing any operational activities.
- Report, investigate and document any abnormal observations, potential risks, discrepancies, deviations and non-conformances in accordance with Hovione internal procedures.
- Timely devise and implement effective and efficient corrective actions / preventive actions (CAPAs), as appropriate.
- Participate in all necessary training as defined in the training plan.
- Report abnormal situations at the installations, as soon as these are detected so that corrective maintenance is triggered in due time.
- Identify the necessary corrective and preventive actions to keep, in a proactive manner, the installation in good conditions.
- Act as the lead process engineer in multiple projects with limited support and liaises directly with customer project teams.
- Updates the Line Manager and the team members on relevant occurrences and trends that may have a significant impact on Area KPIs.
- Provide training on manufacturing processes, production systems and procedures to operational team members
- Participate, as required, in the induction of new colleagues ensuring they are appropriately trained in accordance with established training plans.
- Drive high standards in the production area (e.g. good hygiene, housekeeping and equipment maintenance practices), and act as an advocate for safe operating and high quality performance.
- Support internal stakeholders on, including but not limited to, generation of 3P’s and answering queries on cost and cycle time associated with assigned processes (where applicable)
- Assist with audits and investigations.
- Support the generation / reporting of KPIs for the team and follow all annual performance review requirements, including completion of the self-assessment.
- Contribute to the design of new facilities or to the modification of existing ones.
- Engage in a supportive work environment that allows for open collaboration between team members to share technical knowledge.
- Develop and accumulate strong engineering expertise, sharing knowledge of state-of-the-art technologies and methodologies within the area.
- Initiate and prepare tech-transfers and process improvement projects for established and new processes utilizing best available technology, practices and tools.
- Contributes to the increase of productivity by reviewing, proposing, planning and implementing the introduction of new technologies, methods and practices that have the opportunity to optimize the manufacturing processes.
- Responsible for creating and reviewing cost proposals and project plans when implementing optimization projects.
- Undertake any additional tasks commensurate with the role as and when required
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
