Sterile Products Quality Assurance Specialist
vor 1 Tag
We are seeking an experienced Sterile Products Quality Assurance Specialist to join our team in Basel, Switzerland. The successful candidate will be responsible for supporting the implementation of Annex 1 requirements at our Clinical Supply Centre.
As a member of our Quality Assurance team, you will collaborate with cross-functional teams to ensure the delivery of high-quality sterile drug products that meet regulatory requirements.
The ideal candidate will have a strong understanding of GMP regulations, quality systems, and risk management principles. You will also have experience in qualification/validation and parenteral manufacturing activities.
Responsibilities- Support the implementation of Annex 1 requirements at our Clinical Supply Centre
- Represent Quality Assurance during all activities related to the implementation of Annex 1
- Maintain and support Qualification/Validation and parenteral manufacturing activities
- Collaborate with Quality Assurance Managers within the IMP Quality Operations team
- Provide technical expertise for review and approval of quality-related documents
To be considered for this role, you must have:
- A BS/MS/PhD degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, or equivalent
- At least 2-5 years of experience in a GMP-regulated environment and quality systems
- Experience in Quality Risk Management and performing risk assessments (e.g., FMEA)
- Knowledge of Annex 1 requirements and sterile drug product manufacturing
This is a full-time position with a salary range of approximately €60,000 - €80,000 per year, depending on experience. Our company offers a competitive benefits package, including health insurance, retirement plan, and paid time off.
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Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitAbout Gi Group SAGi Group SA is a leading staffing agency specializing in recruitment services for various industries, including pharmaceuticals.Job DescriptionOverviewThe company is currently seeking a highly skilled Sterile Drug Product Manufacturing Quality Assurance Specialist to join their team in Basel, Switzerland. This role will be responsible for...
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