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Validation and Compliance Specialist
Il y a 3 mois
Job Title: Validation and Compliance Specialist
Company: Meent Life Sciences
Meent Life Sciences is a prominent organization in the life sciences sector, renowned for its expertise in engineering consultancy and clinical research. Our dedication to innovation and excellence allows us to provide customized solutions that meet the intricate needs of our clients in the healthcare industry.
Job Overview:- Collaborate with project teams and engineering to establish a comprehensive validation and qualification strategy.
- Draft and assess qualification framework documents, including User Requirement Specifications (URS), risk assessments, validation plans, and protocols, as well as validation reports, ensuring supplier protocol comments are addressed.
- Work alongside site Quality Assurance to outline Good Manufacturing Practice (GMP) requirements for equipment, facilities, and computerized systems.
- Oversee the preparation and execution of Factory Acceptance Tests (FAT).
- Ensure compliance verification of Design of Experiments (DOEs).
- Monitor equipment compliance from FAT through to Quality Release (QP).
- Coordinate and supervise qualification testing of manufacturing equipment, liaising with both internal and external stakeholders involved in industrial projects, including engineering, quality assurance, production, maintenance, and suppliers.
Location: Southern Lyon
Candidate Profile:Applicants should possess a minimum of 6 years of experience in the fields of qualification and validation.
A proficient level of English is required for documentation purposes.
