EU Qualified Person
1 dag geleden
To provide independent QA/QP 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.
To implement QP release of influenza product(s) to market as required, to include commercial and clinical trials products. To provide oversight of the QA batch release operations and follow up actions associated with PTCs where applicable.
To 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.
To be named Responsible Person for Seqirus Netherlands BV on the WDA and be responsible for safeguarding product users against potential hazards arising from poor distribution practices. The responsible person is authorized to take decisions regarding the distribution of the product.
Responsibilities include: -
- To perform QP release of product(s) to market in compliance with the applicable licenses and legislated requirements for both Commercial and Clinical Trials.
- To 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.
- To complete personal Continuous Personal Development required to maintain QP status
- To 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, and that quality systems are developed and maintained to ensure compliance with regulatory requirements, Seqirus standards & best practice.
- Input into the quality objectives and KPI's for the Batch Release and QA function and to 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.
- To 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
- 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
- To ensure the correct management of third-party distributors and fill finished contract manufacturers in accordance with the Seqirus Quality Manual.
- To provide oversight of Seqirus Netherlands BV operations in relation to the financial ownership and import of unreleased material into the EU.
- To develop and maintain a relationship with regulatory authorities including participation in the inspection process site audits as appropriate
- Ensures that a QMS is implemented and maintained for GDP.
- Approves changes to the processes, activities and procedures.
- Ensures that self-inspections are performed at appropriate regular intervals, following a prearranged programme and necessary corrective measures are put in place.
- Ensures GDP compliant processes for the handling of complaints, returns, suspected falsified products and product recalls.
- Implements and maintains GDP training programme.
- If applicable; ensures that all GDP personnel is trained in GDP, duties, product identification, risk of falsified medicines and specific training for cold chain products.
- Maintains GDP training records.
- Maintains own GDP knowledge and keep up to date.
- Approves any contracted parties which may perform GDP impacting activities for GDP compliance.
- Ensures that suppliers of products to the Seqirus entity are approved prior to procurement.
- Ensures customers of Seqirus are approved and possess a WDA or are authorised or entitled to supply medicinal products to the public
- Ensures that all necessary checks are carried out and that Seqirus products are authorised for sale prior to approving a transfer to saleable stock/
- Responsible for the disposition of returned, rejected, recalled, or falsified products.
Qualifications, Skills and Experience: -
- A degree or equivalent in a life science.
- The candidate should 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.
- A commercial outlook with attention to detail.
- A proactive approach which builds Quality & Compliance into processes.
- A track record in cementing teams and delivering outstanding effectiveness from those teams.
- 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.
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.
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. Learn more about CSL Seqirus.We want Seqirus to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL SeqirusWatch our ‘On the Front Line’ video to learn more about CSL Seqirus
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