Senior Pharmaceutical Quality Assurance Specialist for Sterile Manufacturing
Vor 4 Tagen
We are seeking a highly skilled Pharmaceutical Quality Assurance Specialist to join our team in Basel, Switzerland. As a key member of our Drug Product Services department, you will play a vital role in ensuring the highest standards of quality in the manufacturing of sterile products.
About the Role:- Establish and maintain the Pharmaceutical Quality Management System (PQMS) for the production of sterile products, including combination products.
- Support the organization in compliance matters, including CAPAs, self-inspections, KPIs, and GMP training requirements.
- Collaborate with line functions to create and monitor quality processes related to the relevant parts of the Quality Management System for combination products.
You will be responsible for:
- Authoring and approving guidance documents.
- Serving as the first point of contact for methods, validation, and testing-related issues.
- Tracking GMP status of service providers and SAP material and supplier master data.
Audits and inspections will be an integral part of your responsibilities. You will also act as QA representative for the packaging team by approving methods, laboratory reports, and development activities.
Requirements:- An academic degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related field.
- Significant working experience in Quality Assurance in pharmaceutical industries and GMP environment, preferably in sterile manufacturing.
- Excellent knowledge of EU and US GMP regulations relevant for sterile manufacturing and sound knowledge in manufacturing of combination products/ISO 13485/21 CFR 4/MDR.
The ideal candidate will possess exceptional communication skills, customer focus, and a structured working attitude. Fluency in English is essential, while basic German language skills are desirable.
Estimated Salary: CHF 90,000 - CHF 110,000 per annum-
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