Senior Quality Assurance Specialist
vor 13 Stunden
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Gi Group SA. This role will be responsible for ensuring the quality and compliance of our sterile manufacturing processes.
About the Role
The ideal candidate will have a strong background in quality assurance and experience in sterile drug product manufacturing, qualification, and validation. They will be responsible for supporting the implementation of Annex 1 requirements, maintaining and continuously improving qualification/validation and parenteral manufacturing activities within our IMP Quality Operations unit in Switzerland. The successful candidate will also collaborate with Quality Assurance Managers and other stakeholders to ensure successful delivery of the Annex 1 implementation goals. Additionally, they will provide sound technical and quality assurance expertise for review and approval of quality-related documents and support their area of responsibility at HA inspections and internal audits.
Requirements
To be considered for this role, you must have a BS/MS/PhD degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, or equivalent. A minimum of 2-5 years of experience in a GMP regulated environment and with Quality Systems, Quality assurance, and OT is required. You should also have experience in Quality Risk Management, performing risk assessments (e.g., FMEA), Qualification/Validation, and all activities around parenteral manufacturing. Furthermore, you must be a fast learner, strong team-player with high self-motivation and ability to prioritize, simplify, and connect the dots. Excellent planning and organizing skills, analytical capabilities, and innovative problem-solving abilities are essential for this role. Proficiency in German and English B2 is required.
Benefits
This temporary full-time position offers a competitive salary of $90,000-$110,000 per year, depending on experience. The start date is as soon as possible, and the end date is estimated to be one year, with a very likely extension. The work location is Basel, and remote/home office work is only by exception. Workload is 100%.
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