Senior Scientist Quality Assurance Operations
vor 3 Wochen
We are seeking a highly skilled and experienced Senior Scientist Quality Assurance Operations to join our team at Gi Group SA.
Job Summary:The Senior Scientist Quality Assurance Operations will be responsible for ensuring the quality of our products and processes, implementing and maintaining quality processes, and reviewing and approving operational elements such as procedures and related documents.
Key Responsibilities:- Implement and maintain quality processes for review and approval of master batch records and executed batch records.
- Review and release of purchased materials, internally manufactured materials, and buffer/media assemblies.
- 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.
- Adhere to general cGMP rules, quality policies, procedures, and instructions.
- Actively contribute to continuous quality improvement initiatives and deviation reporting and follow-up.
- Pharmacist, Chemist, Biologist, Microbiologist, Biochemist, or Immunologist with a master's degree or higher.
- 3-5 years of experience in the pharmaceutical industry, with at least 1 year in commercial batch release.
- Knowledge of pharmaceutical manufacturing processes, particularly in biologic drug substance.
- Fluent communication in German and English.
- Experience in SAP and electronic MES is an asset.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Please submit your application documents to zahra.safari@gigroup.ch.
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