Sterile Drug Product Manufacturing Quality Assurance Specialist

Vor 3 Tagen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
About Gi Group SA

Gi Group SA is a leading staffing agency specializing in recruitment services for various industries, including pharmaceuticals.

Job DescriptionOverview

The company is currently seeking a highly skilled Sterile Drug Product Manufacturing Quality Assurance Specialist to join their team in Basel, Switzerland. This role will be responsible for ensuring the quality and compliance of sterile drug products manufactured at the Clinical Supply Centre.

Responsibilities
  • Support and drive the implementation of Annex 1 requirements at the Clinical Supply Centre for sterile drug product manufacturing.
  • Represent Quality Assurance while driving all activities related to a successful implementation of Annex 1 within IMP Quality Operations Switzerland.
  • Maintain and continuously support all qualification/validation and parenteral manufacturing activities within IMP Quality Operation Switzerland.
  • Collaborate with Quality Assurance Managers within IMP Quality Operations Switzerland to ensure seamless operations.
  • Provide technical and quality assurance expertise for review and approval of quality-related documents.
Requirements
  • Bachelor's degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, or equivalent.
  • Minimum 2-5 years of experience in a GMP-regulated environment and with quality systems, quality assurance, and operations (OT).
  • Experience in quality risk management, performing risk assessments, and qualification/validation activities.
  • Fast learner with strong team-player skills, high self-motivation, and ability to prioritize tasks.
  • Excellent planning and organizing skills, analytical capabilities, and innovative problem-solving approach.
Benefits

This role offers a competitive salary range of €60,000 - €80,000 per annum, depending on experience, plus additional benefits such as health insurance, pension plan, and opportunities for professional growth and development.



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