Quality Assurance Expert for Annex 1 Implementation
Vor 2 Tagen
The Gi Group SA is seeking a highly skilled Quality Assurance Expert to join their team in Basel, Switzerland. The ideal candidate will have experience in implementing Annex 1 requirements and driving quality assurance initiatives.
Company Overview
The IMP Quality Operations Unit Switzerland is responsible for ensuring the quality and compliance of Investigational Medicinal Products (IMPs) manufactured and packed in Switzerland. As a Quality Assurance Expert, you will be part of this team and play a crucial role in maintaining high standards of quality and compliance.
Job Description
We are looking for a dedicated individual who can support and drive the implementation of Annex 1 requirements in the Clinical Supply Centre for sterile Drug Product (Parenterals) within IMP Switzerland. The successful candidate will be responsible for representing Quality Assurance while driving all activities related to a successful implementation of Annex 1 within IMP Quality Operations Switzerland.
Required Skills and Qualifications
- Bachelor's or Master's degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, or equivalent
- Minimum 2-5 years of experience in a GMP regulated environment and with Quality Systems, Quality Assurance, and OT
- Experience in Quality Risk Management, performing risk assessments (e.g. FMEA), Qualification/Validation, and parenteral manufacturing activities
- Fast learner, strong team-player with high level of self-motivation and ability to prioritize, simplify, and connect the dots
- Proven ability to work independently and in a team towards results
- Excellent planning and organizing skills to manage multiple tasks at the same time, analytical capabilities, and innovative problem-solving manner
- Fluent in German and English (B2 level)
Estimated Salary: €60,000 - €80,000 per year
Benefits
This full-time position offers a competitive salary, excellent benefits package, and opportunities for professional growth and development.
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