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Quality Assurance Engineer
il y a 1 mois
PharmEng Technology is seeking a Quality Assurance Engineer to join our team in France. As a key member of our Commissioning and Qualification team, you will be responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.
- Perform activities related to commissioning, qualification, requalification, and validation independently.
- Develop and implement qualification protocols and reports, risk assessments, and development protocols.
- Support the development of user requirements and functional specifications.
- Commissioning, qualification, and requalification of new or existing manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines such as GMPs or FDA.
- Qualification of computerized and automation systems.
- Writing of qualification documents such as VP, IQ, OQ, PQ, and PPQ protocols and reports, risk assessments, and development protocols.
- Bachelor's degree in a technical field (engineering, biology, chemistry, pharmacy).
- At least 3 years of experience in QA Oversight for C&Q activities, in Biopharma or Pharma industry.
- Generation and overview qualification documents like URS, System Risk Assessment, DQ, IQ, OQ, PQ, SOPs.