Quality Assurance Specialist Biotechnology

Details

  • Category: Biotechnology
  • Location: Bern area
  • Starting date: Oct 01, 2020
  • Domain of experience: quality assurance, QA, operations, biotechnology
  • Level required: Experienced
  • Years of experience: 5+

Your Role

To join our Aston Life Sciences team of Consultants based in the German-speaking part of Switzerland, we are looking for:

Quality Assurance Specialist

Biotechnology, Operations

Your Tasks

  • Within the quality operations department, the Quality Assurance Specialist assures that all operations meet or exceed cGMP regulations ensuring the quality Bulk Drug Substance
  • Responsible for root cause analysis and corrective action for product and process-related non-conformances related to the biotech production
  • Responsible for quality operations including Change Control, review/audit of data and reports as specified by Standard Operating Procedures
  • In charge of supporting the Analytical Instruments Validation as well as the implementation of laboratory instruments/equipment

Your Profile

  • Minimum Bachelor’s degree, Master degree preferred in a scientific field (Pharmacy, Chemistry, Biology, Biotechnology, etc.)
  • 5+ years of experience in Quality Assurance/Quality Operations in the pharmaceutical or biotech industry (Ideally Drug Substance or API)
  • Excellent knowledge of regulatory requirements, including GMP guidelines
  • Previous experience with systems like Trackwise, MES (Delta V/Syncade) or LIMS is a strong advantage
  • Excellent knowledge of English; French or German is a plus
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