EU Qualified Person
4 dagen geleden
Join CSL Seqirus, a leading global influenza vaccine provider, as an EU Qualified Person. This role is crucial for ensuring the quality and safety of our products.
About the JobWe are seeking an experienced EU Qualified Person to provide independent QA/QC oversight of our Amsterdam testing and release laboratory in Seqirus Netherlands BV. The successful candidate will also be responsible for providing services related to the MIA for the importation of unreleased material into the EU.
The ideal candidate will have experience with vaccines, sterile, and biological products, as well as a commercial outlook with attention to detail. They should be proactive, able to build quality and compliance into processes, and have a track record of cementing teams and delivering outstanding effectiveness.
Key Responsibilities- Perform QP release of product(s) to market in compliance with applicable licenses and legislated requirements.
- Provide oversight of Pharmacovigilance follow-up or recall required in response to Adverse Events and Product Technical Complaint (PTC) investigations and trends.
- Ensure that an effective Quality Assurance function is established in the testing and release laboratory in conjunction with the Head of QA.
- Develop and maintain a relationship with regulatory authorities, including participation in inspection processes and site audits.
- Evaluate GDP compliant processes for handling complaints, returns, suspected falsified products, and product recalls.
- A degree or equivalent in a life science.
- Meet the requirements for EU Qualified Person.
- Vaccines, Steriles, and Biological products experience is preferable.
- Substantial industry experience; vaccines, sterile, and biological experience is preferable.
We offer a competitive salary of $120,000 - $150,000 per annum, depending on experience. Our benefits package includes access to comprehensive health insurance, retirement savings plan, and generous paid time off.
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