This is a 3rd Shift Position- 9:30pm to 6am
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.
- Coordinate warehouse tasks and TMs, implementing all applicable procedures making sure the assigned resources are selected, packaged, loaded and/or dispatched safely, timely and efficiency
- Promote productivity and safety in warehouse activities, by daily scheduling tasks of operators.
- Monitor warehouse operations according to HSE practices, cGMP, cGDP compliance and quality policy
- Ensure that inventories are made and recorded according to procedures
- Maintain records of resources handled according to established processes
- Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks and suggesting process optimizations or improvements
- Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations
- Collaborate in the training of warehouse teams, mainly supporting in the organization of training schedules for the team and ensuring attendance
- Supervise the TMs assigned to his/her area of responsibility and distribute work tasks.
- Provide input to ensure HR processes run smoothly, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies.
- 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
- Ensure area goals are properly cascaded to the team
- 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
Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programs and procedures to safeguard employees and surrounding communities, developing requirements, supporting implementation through training and communication and monitoring implementation through audit and inspection. Conducts and supports incident investigations and risk assessments. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are fully implemented.
- Implement HSE policies, procedures and guidelines in the areas of expertise as requested.
- Create incident reports and perform inspections to ensure conformity in the HSE areas of expertise.
- Conduct internal audits in the HSE areas of expertise.
- Coordinate audits conducted by external parties.
- Assist in development and implementation of HSE systems and standards to facilitate the capturing and analysis of HSE statistics.
- Conduct risk analysis in the HSE area of expertise, proposing mitigation plans in the assigned projects.
- Give support in the investigation of incidents/accidents as required.
- Conduct regular inspections to the sites under responsibility in the HSE areas of expertise, ensuring conformity with all procedures and guidelines.
- Delivery internal training sessions in the HSE areas of expertise.
- 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 HSE 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).
- To assure and promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures and training.
Defines and implements procedures and processes to assure that Hovione Computerized systems are fit for purpose and comply with applicable quality and data integrity standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and data integrity requirements 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.
- Test all computerized systems to demonstrate its compliance with internal and external guidelines (such as 21CFR Part 11, GAMP, EU, PIC/s and ICH) 
- Participate in project teams that require expertise in Computerized Systems.
- Apply a risk-based approach throughout the life cycle of the Computerized Systems taking into account patient safety, data integrity and product quality 
- Implement the defined policies for Computerized Systems life cycle Management 
- Perform validation activities of the Computerized System projects and provide the necessary guidance to ensure compliance with Regulatory and Industry Standards throughout systems’ life cycle 
- Implement data integrity principles during the Computerized System life cycle, as defined
- Collaborate in the definition of the required Qualification and Validation strategies for different Computerized Systems: Analytical equipment, Manufacturing equipment, DCS, PLC and other stand-alone software 
- Issue, review and approve protocols and reports (i.e., DQ, IQ, OQ and PQ), relating to the Validation of Computerized Systems and other validation/qualification documents 
- Review/approve/close corporate Computerized System change controls, deviations, incidents submitted by any Department/Site, to ensure that the system is maintained in an accurate, validated, and compliant state
- Review/approve documentation regarding Computerized Systems data integrity and its life cycle management 
- Provide training and coaching in quality culture and data integrity principles regarding Computerized Systems.
- Support internal, external/ customers’ audits and health authorities’ inspections.
- Perform assigned tasks as planned and deliver on time, safely, efficiently, reliably and in a cost-effective manner 
- Propose improvements to the area as appropriate and solve problems 
- 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.
- Conduct simple tasks of low complexity and with very close supervision
- Rigorously, efficiently and professionally, execute all warehouse activities, AK367 to all applicable procedures and following instructions received from colleagues
- Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks and suggesting process optimizations or improvements
- Develop and accumulate strong warehouse knowledge
- Provide an example of professionalism
- Ensure activities are carried out in compliance with cGMP, HSE, cGDP and all other required processes, legal requirements in the country of operation, complying with and enforcing all Hovione processes and good practice
- Prepare the reception, storage and shipments of all materials and products
- Sample the raw materials for QC and R&D (as required) testing
- Dispense raw materials in line with Production requirements and assure it is done according to the procedures in place
- Monitor and control temperature and/or humidity for each storage location as required
- Perform the physical inventory checking according to the required schedule or procedure
- Collaborate in the investigation and definition of corrective actions/preventive actions for deviations as requested
- Ensure that all equipment is checked and calibrated before use
- Ensure the correct identification and use of equipment (labels, plates, logbooks etc.)
- Ensure correct and in full completion of documentation (e.g. record forms, logbooks)
- Execute warehouse tasks correctly in Hovione systems (including but not limited to SAP, LIMS etc.)
- Use the Personal Protective Equipment and keep it in good condition
- Maintain clean and organized facilities
- Attend and participate fully in all training to which the TM is invited
- Maintain an open communication with colleagues, identifying and reporting any warehouse, safety, environmental, 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
- Use computer programs correctly (including but not limited to email, SAP, LIMS and XNET)
- Collaborate in the revision of the any area documents as requested (IOPs, others)
- Collaborate in internal and external audits / inspections as requested
- Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations
- Collaborate in the integration of the transferred Operators from other areas (where relevant)
- Follow all annual performance review requirements, including completion of the self-assessment
- 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.
- 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 AI367
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.
- Plan, coordinate and supervise the work, with other managers of the area, and manage own team to ensure that the deliverables of each project are dealt in the team within the timeframes defined, with the appropriate quality and according to cGMP and that an outstanding service is provided to all customers (internal and external)
- Assure that all TMs of the team have suitable training in order to guarantee the best possible support to the customer (internal and external)
- Ensure an appropriate information flow between the laboratory and the several internal and external customers
- Participate in external and internal audits
- Approve analytical test methods, reports, protocols and other documents related to the laboratory (as applicable)
- Approve raw material, intermediate and finished product batches, stability samples, validations and/or all samples sent for QC to perform analysis
- Approve In Process and COL samples when necessary
- Assure the availability of International standards and Hovione internal working standards with adequate calibrations/qualifications
- Manage International/In-house Primary and Secondary/Clients' standards and reserve/retention samples
- Assure the qualification of the laboratory equipment and validation of analytical methods, approving the protocols and / or respective reports
- Discuss and propose specifications for raw materials, and intermediate and finished products
- Ensure proper management of all defined stability programs in terms of protocol preparation, inventory management, analytical testing execution and data release
- Ensure that corrective and preventative actions are defined and implemented as a result of deviations occurred in the Area, and of internal and external audits
- Keep up to date on new analysis techniques relevant to the laboratory, by means of literature, training, seminars or conferences
- Assure the timely execution of the preventive maintenance program and execution of corrective maintenance.
- 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 area strategic objectives
- Monitor Communication´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures
- 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
- 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.
Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications.
- In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications
- Contribute to the design review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are dully incorporated
- Execute the construction, assembly, commissioning and qualification of Engineering projects
- Create the installation plan and maintain a close follow up for Engineering Projects
- Guarantee the necessary resources, internal and/or external to meet project plans and to deliver the expected quality on time and on budget.
- Define and implement technical solutions for unexpected challenges during the construction, assembly and commissioning & qualification of facilities without compromising the design concept and the process functionality, quality and systems.
- Report and escalate promptly any relevant deviations to plans or objectives and make quality and timely decisions within the Engineering tasks under her / his responsibility
- Report on a weekly basis the progress of work including any pending items and deadlines.
- Be fully aware of specifications, drawings, work procedures and ensure the contractors receive the adequate documentation and training to perform the work correctly
- Perform change control assessments as per defined standards and procedures in place
- Ensure the change management system is applied correctly and confirm that prior to execution of any additional /extra work caused by scope changes, the proper authorization is obtained
- Plan that relevant inspections and tests are performed in compliance with the Project standards or legal requirements
- Participate, issue, revise and/or approve commissioning & qualification related documentation (i.e.: Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.)
- To coordinate commissioning and/or qualification related activities with involved areas
- When applicable, lead the external qualification contractors assuring the optimal use of their time/cost.
- Perform preparation of the commissioning and qualification activities in coordination with the involved areas (design engineering, assembly, automation, user area, QC and QAU) according to the defined standard and procedures in place
- Guarantee the delivering of commissioned & qualified facilities that can meet user and technical requirements.
- Perform deviation investigations and CAPA implementation as per applicable procedures in place
- On hand-over, guarantee that deliverables were fully commissioned and qualified, when applicable, and are meeting user requirements, cGMP guidelines, internal procedures and customer expectations
- Promote a list of pending items with responsibilities and deadlines (punch list) that do not infringe installation compliance with cGMP and HSE guidelines
- Support the training of the end user to ensure they make best use of the equipment
- Register the user feedback for future learnings
- Apply and develop knowledge of Engineering and participate in area processes, procedures and projects with the guidance of more senior colleagues
- Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Guarantee the compliance to safety and legal rules on the field, coaching all resources involved and liaise with authorities whenever necessary
- Participates in audits performed by clients and health authorities, in the scope of the Qualification and Validation area
- 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, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
- Contribute to the development of the Operational Excellence Roadmap to deliver the long term needs of the organisation by leading the establishment systems such as:
- Tiered Performance Management in production and supporting functions.
- Visual Management.
- Root Cause Problem Solving.
- Production Process Optimisation.
- Standardised Work including Leaders Standard Work.
- Lead the optimisation of Production, QC, Maintenance, and other supporting processes using fact-based analysis.
- Identify the areas for improvement through data analysis and direct observation.
- Identify the appropriate operational excellence tools to deliver and sustain these improvements.
- Lead the implementation of these tools addressing the adoption of new ways of working by team members as well as the technical application of tools.
- Play a leading role in the establishment of a culture and mindset of continuous improvement across the business.
- Influence team members across all levels of the organisation to adopt a new ways of working.
- Coach team members to develop their continuous improvement skills.
- Implement the systems to reinforce a new way of working.
- Synthesise detailed analysis for ease of communication across the organisation, from the production floor to senior leadership.
- Participate in tiered performance management meetings in a coaching role
- 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.
To be responsible for the management of Process and/or Production works/projects assigned to the role on site. Active participation on new projects, technical transfers from other sites, development in scale up and process improvements to established processes.
Responsibilities:
- Implement all Process/Production related projects within area of work in compliance with all relevant legislation and regulatory standards including HSE and Quality, and in accordance with the Project Engineering department ways of work.
- Participate in / lead technical transfer or process improvement projects for established process utilizing best available technology, practices and tool as appropriate at all times. These include the use of Lean Manufacturing Techniques, Risk Assessment Technology, Quality by Design, etc.
- Ensure all project risk assessments are carried out in a compliant manner in line with established SOP’s and policies.
- Responsible for preparation and review of /process engineering documentation including project plans and cost proposals, validation plans and execution of validation activities in relation to projects, preparation of validation reports, etc., correctly in a timely manner, while liaising with the Quality Department as required.
- Responsible for on-time project delivery, projects delivery within budget, maintenance of validation status for all project related equipment to the required regulatory standards.
- Investigate and document process/production and project related deviations, planned deviations, out of specification results and implementation of agreed corrective actions as appropriate.
- Initiate, document, and process change controls for project process/engineering related matters as appropriate.
- Present a written monthly report to the Manufacturing Director providing details on agreed KPI’s and metrics
Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.
- Assigning products or projects to ensure achievement of key area objectives - Manage the cGMP programs (e.g. validation, qualification, stability, environmental control)
- 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 - Identify indicators and actions that envisions standardization and systematization of everyday activities
- Approve, on quality’s behalf, IOPs, change control documents (PdAs) and process related documentation - Evaluate/approve equipment cleaning, qualification protocols and reports
- 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 department strategic objectives - Monitor Communication’s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures.
- 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.
- Responsible for projects associated with the reception of oral tablets and capsules (oral drug product development)
- Understand operational processes and identify areas for improvement that can be addressed through digital solutions
- Work effectively in a team, collaborating with other members of the operational excellence team, as well as with professionals from other areas, such as IT, quality and production.
- Developing dashboards and reports using Power BI
- Connecting data sources, creating effective visualizations, implementing measures and calculating relevant metrics
- Use tools from the Power Platform, and apply this knowledge to improve existing processes
- Lead the development and implementation of the site R&D strategy including alignment with the site objectives and Global R&D
- Responsibility for leading the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs for our Cork site
- Promote the scientific excellence and innovation in the area and contribute with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Establish the main objectives for the area, aligning these with R&D and Hovione’s corporate strategy
- Establish a clear site R&D strategy including resources, capital investment, new technologies etc in order to meet customer and business needs
- Ensure the development of safe, efficient, scalable, timely and cost-effective processes of commercial interest to Hovione
- Identify and assess new business opportunities, trends and market needs, in collaboration with commercial colleagues, and ensure the use of up to date / best technology, processes and work practices
- Facilitate and manage a culture of innovation within the group focused upon creating new technology value and solving existing technical challenges in alignment with the global R&D strategy
- Develop and manage metrics designed to monitor performance and improves efficiencies, quality and HSE culture within the area
- Devise and coordinate the implementation of new procedures or the change of existing ones, according to ruling COPs, SOPs and IOPs
- Represent the R&D area (or nominate delegates) on meetings with clients, external and internal audits and for Product/Project teams.
- Ensure the information flows between the R&D areas, the several internal and external customers and stakeholders
- Promote scientific activities (i.e. seminars, congress participations, innovation ideas, papers and publications), innovation and implementation of new methodologies within the R&D area
- Manage the R&D team including recruitment, integration, training needs and performance management in accordance with the company's HR policies and ensuring the team is aligned and motivated towards achieving Hovione's goals.
- Develop and propose for approval the short and mid-term goals, annual budget and budget plan in line with the corporate strategy, in order to align activities with Hovione's strategic objectives.
- Prepare and propose the annual area budget for the annual site R&D budget.
- 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)
- Supports the companywide financial planning, budgeting and forecasting process
- Supports the group-wide, transparent, consistent, and uniform monthly reporting of essential business performance parameters, including business analyses and comments.
- Supports the group planning processes (target setting, long term planning and budgeting) with the goal of generating - within the defined framework and timeline - a realistic overall picture of all contents relevant to steer and control the business
- Supports the consolidation of the quarterly forecasting processes.
- Maintaining and further development of Company Financial Dashboard including maintenance of company KPI’s
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Evaluate the needs of both the material and human resources for the analytical projects to guarantee that the right analytical support is given in time to customers
- Manage the proposals of alternatives to projects analytical packages
- Support the implementation of new and state of the art analytical methodologies
- Review and approve the analytical test methods to be executed in the laboratory and the protocols, reports and documentation prepared in the Area or provided by the customers
- Ensure the information flow between the laboratory and the several internal and external customers
- Support analytical development activities and investigations, providing guidance and technical analytical consultancy to teams across the organization, particularly in the problem solving process
- Monitor the performance of the group, implementing the necessary measurements for continuous productivity increase
- Promote scientific excellence and innovation within the team and support in the implementation of new technologies/methodologies
- Contribute to the proposal of the Exploration and Investment budgets
- 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 DEPARTMENT strategic objectives
- 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
- 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
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
- 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.
- Coordinate the implementation of new procedures.
- Enforce fulfillment of the GMP and HSE policy, by supporting inspections and liaising with other Areas.
- 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)
- Prepare manufacturing plans for production lines, managing resources allocation and assigning the members responsible (when applicable) for specific tasks.
- Responsible for the accurately and timely preparation, review and approval 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.
- Supervise, execute and ensure, with autonomy, all risk assessments for assigned activities and projects
- 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.
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals.
- Act autonomously as the lead process engineer in multiple projects of high-complexity and/or with significant impact on business and liaises directly with customer project team, promoting active and transparent communication, including in complex situations.
- Provide training on manufacturing processes, production systems and procedures to operational team members.
- Oversee the activities of less experienced Engineers, ensuring that they have the right resources and the right knowledge to do their job and to reach the defined objectives.
- 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)
- Support commercial assessment requests for business evaluation / technical introduction within the area.
- Assist with audits and investigations as SME for Operations.
- Approve changes to facilities and/or equipment trains, when delegated by n+1.
- Promote the transfer of strong engineering expertise amongst other members of team, 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, coordinating and leading the implementation of new technologies, methods and
- Implement the actions derived from approved Area budgets, contributing to costs control and to the achievement of P&L targets.
The role of Global Project Manager ensures that large projects executed in Hovione are compliant with the Engineering Project Practices and are delivered efficiently (safely, on time, on cost and with the expected quality). The incumbent will bring significant experience on operations of Global / Regional Engineering organizations in general and in project management, project controls and the various engineering technical disciplines. The role has responsibilities over Strategic projects defined within Hovione portfolio that are executed throughout the Hovione sites worldwide.
Ensures the proper processes are in place and the necessary governance is well maintained on the projects under his/her responsibility. Works with the projects teams to define the engagement with external EPC/EPCm partners and ensures the proper process and communications to run such projects. Reviews large projects (> 1M) that have been identified as carrying risk and proposes improvement recommendations and / or support (when required) to bring these projects back on track. Update current KPIs for Hovione projects under his/her responsibility ensuring that proper project tracking metrics are in place. Participates in dedicated Steering Committees of the projects under his/her responsibility. All the previous activities will be performed in close link with the various site project managers and project teams across Hovione locations.
- Actively engage and provide professional support to project teams in all areas of Project Management.
- Contribute as SME to the development of governance, processes, and training materials related to Capex Project Management.
- Where appropriate, supports project reviews, to ensure that large projects follow and apply the Engineering processes related guidelines.
- Prepare project reports, updates KPIs and follow up on action plans. · Assist with review and development, issuance and evaluation of subcontract change orders as required for project tracking.
- Works with EPC/EPCm partners to develop the best model for internal and external operation of projects. Works with project teams on the resource and communications plans.
- Develops and implements requirements for project management, reporting, and analyzing standards, programs, and reports.
- Develops and monitors short term (2-4 week) engineering, procurement, construction schedules.
- Monitors schedule deviation for assigned disciplines or specialties including subcontractor submittals and recommends corrective action/workaround solutions.
- Coordinate implementation plan with project site teams and escalate areas of misalignment and improvement.
- Examine requests for budget revisions, recommend approval or denial and draft correspondence. · Assist with update to projections on cash flows, staffing plans and contingency usage.
- Support the change control process, establishing the necessary forms, logs and expediting methods.
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and complying with environmental, health & safety rules/procedures, regulations and codes of practice.
- Maintains the overall Project Management governance and standards aligned with Hovione policies and engineering processes.
- Undertake any additional tasks commensurate with the role as and when required.
Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications.
- In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications
- Contribute to the design review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are dully incorporated
- Execute the construction, assembly, commissioning and qualification of Engineering projects
- Create the installation plan and maintain a close follow up for Engineering Projects
- Guarantee the necessary resources, internal and/or external to meet project plans and to deliver the expected quality on time and on budget.
- Define and implement technical solutions for unexpected challenges during the construction, assembly and commissioning & qualification of facilities without compromising the design concept and the process functionality, quality and systems.
- Report and escalate promptly any relevant deviations to plans or objectives and make quality and timely decisions within the Engineering tasks under her / his responsibility
- Report on a weekly basis the progress of work including any pending items and deadlines.
- Be fully aware of specifications, drawings, work procedures and ensure the contractors receive the adequate documentation and training to perform the work correctly
- Perform change control assessments as per defined standards and procedures in place
- Ensure the change management system is applied correctly and confirm that prior to execution of any additional /extra work caused by scope changes, the proper authorization is obtained
- Plan that relevant inspections and tests are performed in compliance with the Project standards or legal requirements
- Participate, issue, revise and/or approve commissioning & qualification related documentation (i.e.: Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.)
- To coordinate commissioning and/or qualification related activities with involved areas
- When applicable, lead the external qualification contractors assuring the optimal use of their time/cost.
- Perform preparation of the commissioning and qualification activities in coordination with the involved areas (design engineering, assembly, automation, user area, QC and QAU) according to the defined standard and procedures in place
- Guarantee the delivering of commissioned & qualified facilities that can meet user and technical requirements.
- Perform deviation investigations and CAPA implementation as per applicable procedures in place
- On hand-over, guarantee that deliverables were fully commissioned and qualified, when applicable, and are meeting user requirements, cGMP guidelines, internal procedures and customer expectations
- Promote a list of pending items with responsibilities and deadlines (punch list) that do not infringe installation compliance with cGMP and HSE guidelines
- Support the training of the end user to ensure they make best use of the equipment
- Register the user feedback for future learnings
- Apply and develop knowledge of Engineering and participate in area processes, procedures and projects with the guidance of more senior colleagues
- Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Guarantee the compliance to safety and legal rules on the field, coaching all resources involved and liaise with authorities whenever necessary
- Participates in audits performed by clients and health authorities, in the scope of the Qualification and Validation area
- 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, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.
- Guarantee cGMP compliance within the area, by assuring that all necessary procedures are implemented on the site, according to the products requirements and as established in specific Quality and Technical Agreements
- Manage teams and Team Members, ensuring the best organization of work to deliver on the key area objectives
- Manage complex cGMP programs
- Ensure the best structure, tools and prioritization to allow timely and quality release of products
- Ensure that plans are in place to regularly inspect the operational areas to verify compliance with cGMPs
- Lead clients and regulatory audits or inspections as required
- Manage and evaluate regularly data regarding the Key performance indicators established for the area, ensuring actions are taken whenever there are deviations
- Partner with the various areas to identify areas for improvement of how they work together
- Support a continuous improvement mind-set within the area to simplify and streamline how things are done within the area
- Assure that flexibility and simplicity are achieved through an entrepreneurship mind set and a “opt-in/opt-out” of procedures to meet the “fit for use” approach
- Approve complex IOPs, change control documents (PdAs), process and equipment related documentation as required
- 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 area strategic objectives
- Monitor Communication´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures
- 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
- 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.
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 production schedules while managing internal resources (people & equipment) and fulfilling customer requirements.
- Prepare all manufacturing plans for the production lines under their responsibility, managing resources allocation and assigning the members responsible (when applicable) for specific tasks
- Establish the annual objectives for all their direct reports and follow up accordingly
- Oversee the activities of his/her team, assuring that they have the right resources and the right knowledge to do their job and reach the defined objectives
- Support the assessment workflow during projects business evaluation / technical introduction to the area
- Develops areas of human expertise regarding manufacturing execution, in all its components (technical and soft skills)
- Survey the working conditions of the facilities under their responsibility, making proposals for need of investment.
- Revise and approve campaign related documentation, for projects conducted under the supervision of their group
- Enforce fulfillment of the Good Manufacturing Practices (GMP) and HSEE policy, by conducting inspections and liaising with other Areas
- Assure HSE operational program targets accomplishment
- Coordinate and assure on time preventive maintenance program execution and effective / efficient corrective maintenance, for facilities under their responsibility
- 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 the area’s strategic objectives
- Monitor Area´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures
- Build, lead, and mentor a team of functional academy leads
- Lead the development, implementation, and oversight of Hovione Functional Academies.
- Responsible for orchestrating the design, execution, deployment, and continuous improvement of functional academies aimed at enhancing the skills and capabilities of our team members across various functional areas.
- Collaborate with cross-functional teams, subject matter experts, and external partners to ensure the success of each academy.
- Oversee the design and development of curriculum for each academy, ensuring alignment with industry standards, best practices, and organizational objectives.
- Oversee and monitor the deliveries against the deployment plan, risks and mitigation actions to ensure success of each academy.
- Manages, reports and works with internal stakeholders for collaboration and alignment.
- Work closely with subject matter experts to create engaging and impactful learning materials.
- Collaborate with internal stakeholders, including functional representatives and HR, to understand specific training needs and ensure alignment with organizational objectives.
- Works with each academy lead to establish key performance indicators (KPIs) and relevant metrics for each academy (and/or key programs within each) and assess their impact on individual and organizational performance.