QA Associate
- Zurich
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
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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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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