Our biotech client headquartered in Switzerland is currently investing significantly to their manufacturing programme. This state-of-the-art facility houses high-technology and next-gen processes to produce drugs that are distributed throughout the Globe. With over 2000 employees onsite, the site is easily reachable by two major airports and has excellent transport links throughout.
The client is currently seeking the expertise of a QAAssociate to manage the QA interface with manufacturing and testing partners for commercial and clinical large molecules, bulk drug products and commercial finished good products.
Essential Duties and Responsibilities for this QA Associate role include, but are not limited to, the following:
- As the QA Associate you will be responsible managing the Deviations, Complaints and CAPA’s from start to finish.
- You will be responsible for the Regulatory Inspections by coordinating the Preparation of CMO’s and internal departments, along with performing risk assessments.
- As the QA Associate you will manage the quality review and approval for change requests with impact to contract manufacturing or related supply chain operations.
- You will manage the QA interface with manufacturing and testing partners for clinical and commercial molecules API/Bulk Drug Products/Clinical/Commercial finished good products
- The QA Associate will review and approve regulatory files prior to submission and participate in the preparation of annual product quality reviews.
- As the QA Associate you will be qualified to degree level in a scientific topic and have a minimum of 5 years’ experience within a similar position in Pharmaceutical or Biotechnology industries.
- You will have a strong understanding of cGXP’s, quality systems and regulations.
- As a QA Associate you will have gained excellent knowledge of clinical regulations, serialization operations and experience within a manufacturing facility.
The candidate must have the rights to work in the location stated in the job advert.
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