Quality Assurance Specialist for Biologics Manufacturing
vor 1 Woche
We are a leading recruitment agency in the pharmaceutical industry, connecting top talent with exciting job opportunities. Our mission is to provide exceptional staffing solutions that drive business growth and success.
Job DescriptionSalary: CHF 80,000 - 110,000 per year
Gi Group SA is seeking an experienced Quality Assurance Specialist to join our team in Switzerland. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in biologics manufacturing.
Key Responsibilities:
- Implement and maintain quality processes for review/approval of master batch records/executed batch records, including writing of relevant procedures.
- Review and release of purchased materials, internally manufactured materials, including buffer/media assemblies, intermediates, and drug substance, including writing of relevant procedures.
- Review and approval of operational elements such as procedures and related documents, including specifications.
- Assist with continuous improvement initiatives related to quality documents and processes.
- Supervise the preparation of the Annual Product Review (APQR) and guarantee its execution within the due date.
Requirements:
- Bachelor's degree in a relevant field, such as pharmacy, chemistry, biology, microbiology, or biochemistry.
- At least 3-5 years of experience in the pharmaceutical industry, preferably in commercial batch release.
- Knowledge of pharmaceutical manufacturing processes, particularly in biologic drug substance.
- Fluent communication skills in German and English.
- Experience in SAP and electronic MES is an asset.
Benefits:
- Competitive salary and benefits package.
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