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Biopharma Validation Expert
1 week ago
Biopharma Validation Expert
Headcount Solutions is seeking a skilled Biopharma Validation Expert to join our team. The ideal candidate will have a strong background in validation, with experience working on large-scale projects in the biopharma industry.
About the Role- This role will involve leading the development and implementation of validation strategies, as well as ensuring compliance with regulatory requirements.
- You will be responsible for managing a team of validation engineers and coordinating with cross-functional teams to ensure successful project delivery.
- The successful candidate will have excellent communication and problem-solving skills, with the ability to work effectively in a fast-paced environment.
To succeed in this role, you will need:
- A minimum of 6 years' experience in C&Q/QA/QC/Validation in a highly regulated industry.
- Strong knowledge of ASTM E2500/Eudralex/FDA/ISPE guidelines.
- Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS, and QA.
- Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
