Commissioning and Qualification Specialist
il y a 4 semaines
PharmEng Technology is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world. We are seeking a highly experienced Commissioning and Qualification Specialist to join our team in France.
- 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.
- Support the generation and execution of all documentation related to demonstration batches, thermal studies, validation studies for equipment, engineering test runs, development studies.
- 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.
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Commissioning and Qualification Engineer
il y a 4 semaines
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Global CQV Validation Specialist
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Quality Assurance Engineer
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Senior Validation Engineer
il y a 4 semaines
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CQV Engineer
il y a 4 semaines
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CQV Engineer
il y a 4 semaines
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il y a 1 mois
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il y a 4 semaines
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il y a 4 semaines
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il y a 7 jours
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