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Responsibility over the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Participate in strategic automation projects in different company sites;
- Maintain and develop standards, procedures, and specifications for continuous and discrete control, alarms, interlocks, and human-machine interfaces in...
- Participate in strategic automation projects in different company sites;
- Maintain and develop standards, procedures, and specifications for process automation in compliance with internal and external guidelines;
- Manage new equipment recipes and operations development and upgrade across sites;
- Define requirements, plan, and manage strategic automation...
- Utilize advanced knowledge of the discipline to analyze and develop new perspectives on existing solutions;
- Oversee ad-hoc functional or project teams, ensuring effective collaboration and project completion;
- Guarantee that cGMP and HSE requirements are incorporated in the early design phases and throughout the project;
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Apply expertise in a scientific or highly technical area of specialty as an individual contributor or through contributing to/managing project teams in order to achieve results. Entry-level jobs typically require a university degree or equivalent work experience that provides knowledge of and exposure to fundamental theories, principles and practices.
- Provide leadership to teams through subordinate managers or through complex matrix relationships.
- Accountable for the performance and results of multiple (or complex...
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.
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.
Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.
- Assure cGMP compliance in the activities...
- Lead site-specific projects and maintain site automation;
- Prepare detailed execution plans and provide technical oversight during implementation;
- Ensure that project designs align with global standards and guidelines;
- Elaborate functional design specifications, ensuring...
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and...
- Oversee and manage the entire installation process, from initial contracting to final supervision handover to user area;
- Coordinate with subcontractors to ensure timely and efficient project completion, ensuring they receive the adequate documentation and training to perform the work correctly,...
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...
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements.
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Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and...
Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programmes 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 organisation requirements and standards and works to ensure these requirements are fully implemented.
Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.
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...
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 capex...
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 his (her) responsibility, managing...
- Leadership & Team Development:
- Lead, support, and inspire team members (TMs) in recruitment, onboarding, training, and career development;
- Set clear annual objectives for direct reports and provide ongoing guidance to achieve departmental goals;
- Foster a culture of...