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Ensure full compliance with cGMP, GDP, and regulatory requirements across product lifecycle activities, acting as the ultimate authority for batch certification and release. Drive a strong quality culture, safeguard patient safety, and enable business continuity through effective quality oversight and decision-making.
Quality & Compliance Leadership
• Ensure compliance with GMP,...
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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.
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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.
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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.
- Contribute to the area planning and participate in the methodology definition for the...
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- Identify and survey critical instrumentation assets (flow meters, thermometers, pressure and temperature transmitters, etc.) across the plant for which spare parts are currently unavailable.
- Codify identified instruments within the plant's asset management framework, ensuring full...
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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.
- Apply and develop QC knowledge while participating in procedures and...
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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.
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- Lead in‑depth analysis of pharmaceutical markets, competitors, technologies, and customer dynamics.
- Anticipate external trends and strategic risks, assessing their implications for long‑term business direction.
- Leverage advanced analytics and emerging technologies (including AI) to synthesize complex intelligence from diverse sources.
- Translate sophisticated analyses into clear, actionable insights tailored to senior and functional...
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- 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...
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Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.
- Fulfill all applicable current Good Manufacturing Practices (cGMP) and Health...
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- 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 medium to high degree of complexity including
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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...
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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.
- Coordinate and supervise activities within the area and prioritize activities in case of...
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Partner with stakeholders across functions as a data business partner, identifying high impact use...
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The HSE Global Compliance Director is a senior, independent oversight role responsible for establishing, governing, and continuously strengthening Hovione’s global Health, Safety & Environmental (HSE) compliance systems. As the HSE Global Compliance Director you will ensure that all sites operate in full adherence to applicable regulations, internal standards, and major accident hazard prevention requirements—regardless of operational constraints or local decision‑making considerations.
As a key member of the Global HSE Leadership Team, the...
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Ensure efficient and compliant manufacturing of pharmaceutical products, including highly potent compounds, following cGMP, HSE, and business requirements;
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Organize, execute, and autonomously perform production activities according to procedures, instructions, and established schedules;
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Complete, maintain, and ensure accuracy of all required production documentation and equipment...
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Oversee and supervise all production activities to ensure efficient, safe, and right‑first‑time operations aligned with cGMP, HSE, and business requirements;
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Promote a strong safety and quality culture by identifying risks, implementing mitigation actions, and ensuring compliance with all regulations and standards;
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Drive continuous improvement by proposing and implementing optimizations in...
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Job Purpose
The Design Engineering Manager is responsible for leading all design engineering activities, from early process design through detailed engineering, ensuring projects are technically sound, compliant with GMP and EHS requirements, cost-effective, and ready for efficient execution. This role bridges process understanding and engineering discipline coordination, guaranteeing that project designs are fit for purpose, constructible, and aligned with business and operational needs.
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Performs Engineering Design, Project Management, and Technical Support activities to Site Operations including Research and Development. Designs, procures, installs and qualifies processes, equipment, instruments, and tests manufacturing facilities to meet quality, safety, and productivity standards. Plans, designs and oversees construction and maintenance of structures, facilities, systems and components. Analyses and develops solutions to engineering problems related to manufacturing equipment and systems or the causes of component failures. Develops and applies engineering standards and procedures, guidelines and legal requirements...
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Performs engineering and associated support activities in operations, production, construction or maintenance environments. Designs and installs processes, instruments and equipment and tests manufacturing facilities to meet quality, safety and productivity standards. Plans, designs and estimates time and cost and oversees construction and maintenance of structures, facilities, systems and components. Analyses and develops solutions to engineering problems related to manufacturing equipment and systems or the causes of component failures. Develops and applies engineering standards and procedures, guidelines and legal requirements and provides...