Commissioning and Qualification Specialist

il y a 4 semaines


Orléans, Centre-Val de Loire, France PharmEng Technology Temps plein
About the Role

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.
Key Responsibilities
  • 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.
Requirements
  • 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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