Overview
As a Qualified Person, you will certify medicinal product batches to meet regulatory and quality standards while leading continuous improvement within the quality system. You will work with cross-functional teams to ensure GMP compliance and conduct audits to uphold regulatory standards. This role places you at the heart of product release and quality assurance in a fast-paced pharmaceutical environment. It offers the chance to shape release processes and strengthen quality governance across the organization.
Responsibilities
- Certify batches of medicinal products before release to ensure regulatory and quality compliance
- Oversee the quality management system and drive continuous improvement
- Collaborate with cross-functional teams to ensure GMP compliance
- Conduct audits and inspections to maintain regulatory compliance and identify areas for enhancement
Key requirements
- Relevant degree in a scientific discipline
- Extensive industry experience in pharmaceutical quality assurance
- Experience of releasing IMPs is essential
- attention to detail
- cross-functional collaboration
- audit and inspection mindset
- GMP knowledge
- quality management systems
- batch release
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