Quality Assurance Specialist

vor 2 Monaten


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
Job Description

We are seeking a highly experienced Qualification Expert to join our team at Gi Group SA. As a key member of our quality assurance team, you will be responsible for planning and conducting qualification and validation activities, creating and reviewing qualification and validation documents, and ensuring compliance with internal and external regulatory requirements.

Key Responsibilities:
  • Plan and conduct qualification and validation activities to ensure compliance with GMP regulations
  • Create and review qualification and validation documents, including SOPs and manufacturing specifications
  • Maintain the qualified and validated status of rooms, infrastructure, and equipment
  • Collaborate closely with other departments to ensure effective communication and compliance
  • Provide assistance in the processing of deviations, changes, and CAPAs
Requirements:
  • Technical degree or relevant work experience in qualification with GMP
  • Further training and hands-on experience in the area of GMP
  • Min. 3-5 years of experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industry
  • Several years of hands-on work experience in qualification is a must
  • Experience with Siemens COMOS, EVAL, and VIVA is a plus
What We Offer:
  • 100% workload
  • 20% remote/home office possible
  • Opportunity to work with a leading recruitment agency in the pharmaceutical industry

Please apply online for this exciting opportunity to join our team at Gi Group SA.



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