- To develop, set and implement Process Validation/Product Performance Qualification (PPQ) and Continued Process Verification (CPV) procedures using Risk Management tools.
- To oversight Validation status of Hovione's products looking for improvements and rationalization of activities. To establish and monitor product performance indicators and analyze trends.
- To assure compliance with the standards set for Product Lifecycle in all Hovione's Sites.
- To improve Hovione's Quality System either for including new methodologies, modern pharmaceutical technologies implemented or for standardizing and simplifying procedures and practices.
- To open and maintain active and efficient communication channels with each Site QA in order to implement the best practices, across Hovione.
- To keep the area up to date with Process Validation (PPQ)/QRM , and Cleaning guidelines, assuring internal training and documentation revision.
** CVs in English only**
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)
As a Supply Chain Global Planning Trainee at Hovione, you will play a vital role in supporting the comprehensive understanding and optimization of our end-to-end Global Supply Chain for Products and Services. You will have the opportunity to directly collaborate with diverse teams across various sites, including Manufacturing, R&D, Quality, Project Management, and more.
Key Responsibilities:
- Collaborate with cross-functional teams to identify, analyze, and recommend improvements in end-to-end supply chain processes.
- Support digitalization initiatives by assisting in the implementation and integration of digital tools and technologies to enhance supply chain efficiency and effectiveness.
- Conduct data analysis to identify trends, patterns, and insights that can drive informed decision-making within the global planning team.
- Provide proactive support to the team in various projects, ensuring tasks are organized and executed in a timely and efficient manner.
- Collaborate with team members to develop and document standard operating procedures (SOPs) and best practices for supply chain planning activities.
As a Supply Chain Global Logistics Trainee at Hovione, you will play a vital role in supporting the comprehensive understanding and optimization of our end-to-end Global Supply Chain for warehousing & Transportation. You will have the opportunity to directly collaborate with diverse teams across various sites, including Manufacturing, R&D, Quality, Project Management, and more.
Key Responsibilities:
- Assist with data collection and analysis to identify areas for process improvement within the logistics department.
- Participate in process mapping exercises to document and visualize current workflows.
- Research and propose innovative solutions for improving efficiency, reducing waste, and optimizing logistics operations.
- Support the implementation of process improvement initiatives, including creating training materials and assisting with change management.
- Maintain accurate and up-to-date documentation of processes and procedures.
- Collaborate effectively with cross-functional teams, including warehouse personnel, transportation providers, and other logistics stakeholders.
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Organize and execute Production activities;
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Be responsible for operating the equipment, keeping the facilities under your responsibility clean and organized;
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Ensure that the equipment is checked and calibrated before being used;
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Ensure the correct identification and use of equipment (labels, signs, logbooks);
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Prepare samples of intermediate products and final products;
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Maintain Personal Protective Equipment in good condition;
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Use computer programs correctly;
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Collaborate in the review of documents in the area;
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Collaborate in internal and external audits/inspections;
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Participate in the training of new Operators (Production, GMP, HSEE).
- Fulfill all applicable current Good Manufacturing Practices (cGMP) 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, 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 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;
- Act as a delegate of the lead process engineer and takes an active role liaising with Hovione and 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 to operational team members ensuring they are appropriately trained to perform the process related tasks;
- Follow all annual performance review requirements, including completion of the self-assessment.
- 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.
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.
- Ensure the effective and proactive flow of information and requests between the QC team and the internal and external (if applicable) stakeholders
- Participate in meetings with internal and external customers as representative of analytical area, providing information on the status of activities
- Provide collaborative and timely support in the resolution of analytical problems relating to assigned projects / initiatives
- Propose and prepare changes to QC procedures or analytical methods for onwards approval and implementation
- Assure product specifications are maintained in accordance with appropriate standards and propose revisions as required
- Issue and follow-up change controls
- Assure good functioning equipment, planning and managing the maintenance, internal calibration plans, reference standards and internal qualifications of designated laboratory instruments
- Accurately use and maintain all laboratory information systems, participating in the implementation of lab systems improvements as required
- Prepare protocols, reports, QC documentation and review records to ensure compliance with cGMP and HSEE standards
- Request quotations and propose the acquisition of instruments, materials and reagents to guarantee the stock control and operation of the laboratories
- Manage reserve/retention samples
- Initiate events and deviations in the CAPA system in accordance with the required timeframes and in partnership with appropriate colleagues, complete relevant section/s of the event or deviation
- Lead and participate in root-cause investigations, guiding colleagues (as required) in the necessary investigative testing, and ensuring appropriate corrective and preventative actions are determined
- Determine the root cause of events and deviations based upon the data and information obtained through the investigation, ensuring appropriate corrective and preventative actions are determined
- Complete or support the completion/close out of OOS/OOT laboratory deviation investigations and QC incidents
- Monitor progress and follow-up corrective and preventative actions
- Monitor the status of open events and deviations and provide periodic status reports to QC management
- Assess the impact of changes to facilities/systems/equipment/stability and processing of change control documents
- Perform periodic checks of laboratory documentation to ensure compliance with applicable operating procedures and identify and implement updates/improvements to current procedures
- Be an advocate for safe operating and high-quality performance within the area, alerting the management of the area to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements
- Prepare and participate in internal/external audits as requiredSupport the compilation of audit responses for QC
- 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
- Make quality and timely decisions within the 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)
- 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.
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
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
This person will manage all instrument and electrical maintenance activities at our Loures site, both preventive and corrective. Will also manage our instrument calibration workflow.
- Contribute to the implementation of strategies on the design, acquisition and maintenance of facilities and equipment to guarantee the maximum reliability of the company assets.
- Provide technical solutions for unexpected events during the life cycle of installations and return such learnings to the ones in charge for engineering standards.
- Advise in the selection outsourced engineering, maintenance or facility contracts and resources to meet site requirements.
- Ensure that continuous improvement and lean thinking is used in all departmental activities
- Select the best performers for career advancement in accordance with the organization needs.
- Manage and support 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
- Establish the annual objectives for all of his/her direct reports and follow up accordingly.
- 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.
- Guarantee that facilities respect Regulatory, National laws and Health authority requirements.
- 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 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.
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.
- Perform and lead the Group Members to perform project management according to the principles defined by industry standard methodologies such as PMI PMPMBOKMBOK and in compliance with internal processes and requirements.
- Promote the continuous development of the Project Management Group Members so that they can set and maintain standards of excellence in Hovione project execution and management for all Customers as well as internal stakeholders.
- Assure the motivation of the Group Members by encouraging and offering them challenges that lead to an increase of knowledge within the area of Project Management as well as implementation of best practices, standardized approaches and process simplification related with Project execution and management at Hovione.
- Contribute for efficiency improvements in other areas that impact directly with the Project Management Group functions.
- Ensure proactive and transparent communication internally and with the Customer.
- Support definition of invoice schedule CRM CRM and request invoices (RD)CRM CRM according to the Payment schedule defined in the contracts with Customers.
- Coordinate TMs 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 TMs 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 the area’s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures.
- Ensure compliance with internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedurCOPsCOPs, HBR, SOPs and others) within his/ TMs TMs.
- Comply with all applicaGMP GMP HSE HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedurCOPsCOPs, HBR, SOPs and others) within his/ TMs TMs.
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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.
- Propose and implement complex and thorough 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.
- Lead internal audits in the HSE areas of expertise.
- Lead audits conducted by external parties.
- Propose and implement complex HSE systems and standards to facilitate the capturing and analysis of HSE statistics.
- Conduct complex risk analysis in the HSE area of expertise, proposing mitigation plans in the assigned projects.
- Lead the investigation of incidents/accidents as required.
- Lead regular inspections to the sites under responsibility in the HSE areas of expertise, ensuring conformity with all procedures and guidelines.
- Coordinate key HSE projects with operating and other technical units, guaranteeing the execution of the project.
- Contribute to the HSE training strategy and propose training goals and contents.
- Coach senior members of the company in HSE practices and principles.
- Delivery internal training sessions in the HSE areas of expertise to key people in the organization.
- Keep abreast of new legislation and regulations in HSE in the regions and area of expertise under responsibility.
- Demonstrate track record in HSE.
- Solve complex problems with full autonomy.
- Make quality and timely decisions based on multiple sources of data and regarding a wide array of subjects.
- Manage risk and uncertainty; anticipate and address roadblocks in order to prevent deviations to the goals.
- Coach project team members to enhance company effectiveness and promote achievement of high standards within the organization.
- 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.
Delivers win-win cost-effective solutions on time and in full through a Team of Project managers leading 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. Enable and coach the Project Managers to 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.
Main responsibilities:
- Lead the development of the Project Management area vision, strategy and measures, ensuring these are aligned to the overall business, in collaboration with the Senior Director PMO.
- Develop and sustain standardized PM processes, implemented in a consistent and repeatable manner.
- Oversee the integration of program and project processes
- Develop organizational governance frameworks, hierarchies, and relationships
- Monitor portfolio, program, and project performance (actual versus planned) and key performance indicators.
- Implement a PM continuous improvement system, to optimize the existing processes and adapt to new challenges and realities, in the line with the overall Corporate PMO strategy
- Facilitate organization-wide stakeholder engagement and agreement, actively contributing to customer satisfaction
- Control area deliverables and ensures they are completed on time and in full and within budget, thereby exceeding customer expectations
- Assign program and project managers to programs and projects
- Manage 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 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 strategic objectives
- Prepare and propose for superior approval the annual area budget, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen and taking corrective measures.
- Active member of the site leadership team influencing the strategic direction of the site and bringing the customers’ perspective to the attention of the SLT
- 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) within his/ her TMs
- Define key asset management strategy (preventive maintenance plans, identify critical spare parts, optimize spare parts inventories, update equipment BOM);
- Knowledge on condition-based maintenance techniques, such as vibration analysis, NDT for pipping, welding, etc;
- Integration of maintenance procedures in the maintenance management system (SAP);
- Knowledge on reliability standards RBI, RCM, SIL;
- Troubleshoot problems in the event of equipment malfunctions and be able to execute RCA to identify effective corrective actions;
- Analytical skills for historical data to identify low performance assets and life cycle analysis to independently equipment overhaul or replacement;
- Participate in definition and assure follow-up of key performance indicators (KPI) of maintenance and reliability;
- Establish action plans to continuously improve maintenance performance based on state-of-the-art solutions to improve equipment reliability;
- Observe and respect national legislation (DL191/2019, DL50/2005);
- Guarantee that cGMP rules and procedures are respected within the area, assure that outsource contractors acknowledge internal procedures;
- Ensure all assigned tasks are planned and delivered on time, efficiently, reliably and in a cost-effective manner, and with safety first mindset;
- Propose improvements to the area as appropriate and solve problems.
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.
