Quality Assurance Specialist

Vor 2 Tagen


Bern, Bern, Schweiz Randstad Vollzeit
Job Description

Randstad is seeking a Quality Assurance Specialist to join our team in Bern. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of laboratory equipment and systems in a GMP environment.



Key Responsibilities:
  • Perform system life cycle activities such as periodic access reviews and system audit trail reviews for laboratory equipment.
  • Coordinate/support timely and effective completion of QC equipment related investigations, change controls and CAPA's.
  • Perform update of equipment related technical documents such as SOPs, Work-Instructions and forms.
  • Support in equipment/system qualification and validation activities.


Requirements:
  • Extensive technical know-how of QC Lab equipment (computerized and non-computerized) and corresponding system life cycle activities such as periodic reviews.
  • Min 10 years relevant industry experience.
  • Proven experience in equipment system life cycle activities, equipment qualification and system validation in a GMP environment. Good knowledge related to regulatory environments in the life science industry (GAMP 5, 21 part 11,..)
  • Experience with processing of QC equipment related non-conformances, CAPA's and change controls.
  • Know-how of commissioning, qualification, validation requirements and system life cycle activities according to c(GMP) regulations in a laboratory environment.
  • Must be well organized, a self-starter, results oriented individual with the ability to multitask in a fast-paced team environment with attention to detail and good documentation practice.
  • Good verbal and written skills in English, German is a plus.


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