EU Qualified Person
7 dagen geleden
To provide independent QA/QC oversight of the Amsterdam testing and release laboratory in Seqirus Netherlands BV and provide services to Seqirus Netherlands BV in relation to the MIA for the importation of unreleased material into the EU. Ensure that appropriate quality standards and systems are in place and applied across the Amsterdam testing and release facility in accordance with regulatory and Seqirus global requirements.
Main Responsibilities:
- Perform QP release of product(s) to market in compliance with the applicable licenses and legislated requirements for both Commercial and Clinical Trials.
- Provide oversight of Pharmacovigilance follow up or recall required in response to Adverse Events and Product Technical Complaint (PTC) investigations and trends in line with regulatory requirements.
- Complete personal Continuous Personal Development required to maintain QP status and ensure that an effective Quality Assurance function is established in the testing and release laboratory in Seqirus Netherlands BV in conjunction with the Head of QA.
- Ensure quality systems are developed and maintained to ensure compliance with regulatory requirements, Seqirus standards & best practice.
- Input into the quality objectives and KP I 's for the Batch Release and QA function and ensure these objectives are met and that continuous improvement is demonstrated.
- Ensure Site Master File and Quality Agreements with the manufacturing site Quality functions and R&D QA are maintained.
- Provide QA/QP oversight of the testing and release functions in Seqirus Netherlands BV and contribute effectively towards the strategic development of site systems.
- Execution of Management Reviews for Seqirus Netherlands BV and escalation of issues to Global Quality Committee.
- Establish process for annual product review for Seqirus Netherlands BV and completion of the review annually.
- Host regulatory inspections and self-inspections for Seqirus Netherlands BV and ensure vendor verification checks (relating to internal Seqirus entities) is up to date.
- Manage QA Associate(s) for Seqirus Netherlands BV, ensure they are appropriately training for their required activities and ensure the correct management of third-party distributors and fill finished contract manufacturers in accordance with the Seqirus Quality Manual.
- Provide oversight of Seqirus Netherlands BV operations in relation to the financial ownership and import of unreleased material into the EU and develop and maintain a relationship with regulatory authorities including participation in the inspection process site audits as appropriate.
Qualifications, Skills and Experience:
- A degree or equivalent in a life science.
- The candidate should meet the requirements for EU Qualified Person and have substantial industry experience, vaccines, sterile and biological experience is preferable.
- A commercial outlook with attention to detail and a proactive approach which builds Quality & Compliance into processes.
- A track record in cementing teams and delivering outstanding effectiveness from those teams and the ability to deal with complexity and uncertainty and to remain calm under pressure.
- A good track record with the FDA, MHRA, EMEA and other regulatory agencies.
About CSL Seqirus:
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.
Why Join Us:
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives, with a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion and offers a wide range of benefits and opportunities for career growth and development.
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