Quality Assurance Specialist
2 weken geleden
At Corbion, our mission is to lead in preservation across various domains, safeguarding food, health, and the environment.
The Quality Assurance Specialist plays a crucial role in ensuring that processes, systems, and protocols align with Quality and Regulatory standards while meeting the needs of the Biomaterials sector. The ideal candidate will possess extensive experience in the pharmaceutical, medical device, or similar FDA-regulated environments. A comprehensive understanding of ISO 9001, ICH Q7, CFR 210/211, CFR 820, ISO 13485, and other relevant regulations is essential. In this role, you will serve as the quality authority in strategic initiatives involving the launch of new production methodologies and/or products.
Key Responsibilities:
- Assist in the upkeep and ongoing enhancement of the Quality Management System, ensuring compliance with GMP standards and ISO regulations.
- Deliver compliance and quality training to the Operations, Research and Development, and Quality Control teams.
- Collaborate with internal stakeholders and both internal and external clients to ensure that Quality and Regulatory needs for strategic initiatives are recognized and integrated into project plans.
- Lead the development of an effective quality control strategy for new processes and products by employing quality risk management principles throughout various stages of strategic projects.
- Support Commissioning, Qualification, and Validation efforts, including the necessary documentation for new machinery.
- Enhance quality risk management protocols to guarantee regular reviews and performance assessments.
- Stay informed about FDA, EMA, and other international regulations, guidelines, and standards (such as ICH, USP, Ph. Eur.) pertinent to the industry. Monitor legislative changes and adapt them for the Biomaterials sector.
- Conduct annual reviews of commercial products.
- Assist the QA department with Audits, CAPA's, Change Control, Deviations, Root-Cause Analysis, Non-Conformance, and Complaint management.
About You:
- Possess a Bachelor's or Master's degree in Chemistry, Engineering, Life Sciences, or a related field.
- Have a minimum of 5 years of experience as a Quality Assurance Specialist in pharmaceutical, medical device, or similar industries.
- Demonstrate experience with Commissioning, Qualification, and Validation processes for new production equipment.
- Exhibit proficiency in applying Quality Risk Management principles and tools (ICH Q9, FMEA, HACCP, HAZOP, etc.).
- Possess a working knowledge of ISO 9001, ICH Q7, FDA CFR 210/211, CFR 820, EU GMP, EU MDR, ISO 13485, and other relevant regulations.
- Show strong written and verbal communication skills in English, with a preference for Dutch proficiency.
- Have some experience with customer audits and/or regulatory agency inspections (e.g., FDA, notified bodies).
- Demonstrate a proven ability to collaborate across functions to achieve business objectives.
- Exhibit attention to detail, a commitment to quality, accuracy, efficiency, and consistency.
- Be willing to travel occasionally as required by business needs.
About Corbion:
Corbion stands as the global leader in lactic acid and its derivatives, as well as a prominent supplier of emulsifiers, functional enzyme blends, minerals, vitamins, and algae-based ingredients. Our expertise in fermentation and other processes enables us to provide sustainable solutions for the preservation of food, health, and the environment. With over a century of unwavering dedication to safety, quality, innovation, and performance, we collaborate closely with our clients to implement our advanced technologies effectively. Our solutions enhance product differentiation in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics.
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