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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
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
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.