Qualification and Validation Specialist
il y a 2 semaines
Job Title: Qualification and Validation Specialist
Company: Meent Life Sciences
Meent Life Sciences is a leading company in the life sciences field, providing strong expertise in engineering consultancy and clinical research. Our commitment to innovation and quality enables us to deliver tailored solutions to address the complex challenges of our clients in the health sector.
Job Responsibilities:- Develop and implement qualification and validation strategies in collaboration with project teams and engineering departments.
- Prepare and review qualification framework documents, including URS, risk analysis, plans, protocols, test sheets, and validation reports.
- Collaborate with site QA to frame GMP requirements for equipment, premises, and computerized systems.
- Plan and execute Factory Acceptance Tests (FAT) and verify compliance of Design of Experiments (DOEs).
- Check equipment compliance from FAT to Qualified Person (QP) certification.
- Coordinate qualification tests of manufacturing equipment with internal and external stakeholders, including engineering, quality, production, maintenance, and suppliers.
Requirements:
Minimum 6 years of experience in qualification and validation.
Good level of English for documentation writing.
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