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16307en
- Contract
- English, German
- Associate
- Research & Development
- Bern
- Healthcare & Life Sciences
Skills
Quality Assurance, Aseptic Cleanrooms, Sterility Assurance, Pharma, Biotech, GMP
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On behalf of our client, a leading biopharmaceutical company, Swisslinx is seeking a Quality Assurance Architect.
Location: Bern
Start date: Asap
Duration: 6 months’
Workload: 100%
Your mission:
• Supports creation and implementation of the aseptic operator training program for the site Bern
• Creation and update of procedures and risk assessments
• Ensures adherence to the company’s global procedures and standards
• Creation of SOPs in aseptic processing (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)
• Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)
• Supports Annex 1 Gap mitigation and remediation in collaboration with the manufacturing department (e.g. creation of work instructions, risk assessments, process design)
Your background:
• Language: German and English Business Level
• Education: Degree in Life Sciences
• 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
What’s on Offer?
• A fantastic opportunity to advance your career.
• Be part of an innovative team with a great company culture.
Interested?
Apply now or reach out directly to Veronika von Mentzer, Recruiter: veronika.nakev@swisslinx.com
Location: Bern
Start date: Asap
Duration: 6 months’
Workload: 100%
Your mission:
• Supports creation and implementation of the aseptic operator training program for the site Bern
• Creation and update of procedures and risk assessments
• Ensures adherence to the company’s global procedures and standards
• Creation of SOPs in aseptic processing (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)
• Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)
• Supports Annex 1 Gap mitigation and remediation in collaboration with the manufacturing department (e.g. creation of work instructions, risk assessments, process design)
Your background:
• Language: German and English Business Level
• Education: Degree in Life Sciences
• 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
What’s on Offer?
• A fantastic opportunity to advance your career.
• Be part of an innovative team with a great company culture.
Interested?
Apply now or reach out directly to Veronika von Mentzer, Recruiter: veronika.nakev@swisslinx.com
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