Quality Assurance Specialist for Pharmaceutical Operations
vor 19 Stunden
Gi Group SA is seeking a highly skilled Quality Assurance Specialist to join our team in Basel. As a key member of our Global Technical Operations department, you will be responsible for ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland.
The Clinical Supply Centre in Basel is responsible for manufacturing Sterile Drug Products for clinical studies. In light of the implementation of Volume 4 EU Guidelines for GMP Annex 1, we are looking for an individual who can support and drive end-to-end the full implementation of Annex 1 requirements. This includes collaborating closely with all involved parties from the Clinical Supply Centre Parenterals and overseeing the execution of cGMP activities.
The ideal candidate will have sound Quality Assurance knowledge and experience in the area of Annex 1 implementation, sterile Drug Product Manufacturing, Qualification and Validation as well as parenteral manufacturing activities. Responsibilities include:
- Supporting and driving the implementation of Annex 1 requirements during implementation in the Clinical Supply Centre for sterile Drug Product (Parenterals) within IMP Switzerland
- Representing Quality Assurance while driving all activities related to a successful implementation of Annex 1 within IMP Quality Operations Switzerland
- Maintaining and continuously supporting all Qualification/Validation and parenteral manufacturing activities within IMP Quality Operation Switzerland
- Collaborating with Quality Assurance Managers within IMP Quality Operations Switzerland
- Providing sound technical and quality assurance expertise for review and approval of quality-related documents
In order to succeed in this role, you should possess a strong understanding of GMP regulations and quality systems, as well as excellent planning and organizing skills. A Bachelor's or Master's degree in a relevant field such as Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, or equivalent is required, along with at least 2-5 years of experience in a GMP-regulated environment.
We offer a challenging opportunity to work in a dynamic environment and contribute to the success of our organization. If you are a motivated and detail-oriented professional with a passion for quality assurance, we encourage you to apply for this exciting position.
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