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Quality Assurance Specialist – (5014-LBD)
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for an QA Specialist for 12 month contract role based in Basel, Switzerland.
The QA Specialist is a member of the QA Operations Team that is responsible for the quality oversight of the production and other operational units within the client's manufacturing. The team ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the operational units.
- Responsible for managing quality aspects within the area of responsibility
- Ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Quality Manual and is conducted according to the relevant Standard Operating Procedures
- Execute batch release in compliance with registration
- On time and GMP compliant release of dosage forms
- Independent, flexible processing of all activities related to the release of product during clinical and commercial manufacturing
- Technical release of primary packed and finished product, media and apheresis
- Evaluation and decision of deviations and out-of-specification including robust CAPA management, review/approval of batch related quality relevant documents ( e.g. review/ approval of MBRs, review/ approval of executed batch records
- Audit and inspection support.
- Leads or contributes to selected cross-functional and high priority projects in alignment with GCS strategy, from start to completion.
Qualifications and Experience:
- Swiss working/residency permit and/or Swiss/EU-Citizenship required
- Bachelor of Science or Master of Science in Biology, Chemistry, Biochemistry, Microbiology or other related science
- Good understanding of cGMP
- Fluent English, German skills desired
- 3-5 years of experiences in pharmaceutical QA, QC or production environment; IT-Knowledge (MS Office, SAP, Trackwise, MES)
- Ability to communicate clearly with a variety of individuals across different departments in a matrix organization