Quality Assurance Aseptic Process Specialist (5508 – ADA)
Our client, a large pharmaceutical organization, is looking for a German speaking Quality Assurance Specialist with experience in Aseptic Processing for a 12-month contract (with a high possibility of an extension for another year) in Bern to support the creation and implementation of Aseptic Operator training program.
- Support creation and implementation of the aseptic operator training program
- Create and update of procedures and risk assessments
- Ensure adherence to global procedures and standards
- Create training content in the area of aseptic processing (Microbiology, Hygiene, Aseptic Behavior, Transitional spaces, gowning procedures)
- Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behavior, Transitional spaces, gowning procedures)
- Support Annex 1 Gap mitigation and remediation in collaboration with the manufacturing department (e.g. creation of work instructions, risk assessments, process design)
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance.
- Experience in the pharmaceutical manufacturing industry, specifically aseptic processing
- Demonstrated experience in quality assurance and regulatory compliance with EU GMP Annex 1
- Languages: German and English Business Level
Background in Sterility Assurance, Sterile Manufacturing, Quality on the Floor or similar would be highly preferred.