Quality Assurance Associate CSL Seqirus Amsterdam

The QA associate will support the QP on all QA activities for the Amsterdam site of Seqirus Netherlands B.V. Quality Assurance for Seqirus Netherlands and will support the testing and release laboratory commercial batch release activities and clinical batch release activities.

This role is a hybrid role and will require on site presence 3 days a week minimum.

Responsibilities include: -

• Performs monthly checks on the QC facilities and data integrity.
• Reviews and approves validation protocols and reports and oversees validation activities.
• Review and approval of procedures minor deviations and CAPAs for the QC laboratory.
• Attends weekly compliance meeting and regular tiered accountability meetings with QC.
• Support annual retain inspection and inspection of retains for complaints/deviations.
• Collates and reviews batch documentation and recommends batch disposition for QP approval.
• Preparation submission and tracking of national competent laboratory submissions for batch release.
• Supports data collation for the QP relating to IMP release
• Owns and approves quality assurance related minor deviations CAPAs and change controls including relating actions.
• Owns and investigates Product Technical Complaints for EU markets.
• Implementation of regulatory commitments.
• Maintenance of quality agreements site master file and QA procedures relating to Seqirus Netherlands B.V.
• Supports the QP in activities relating to audits and self-inspections recalls and mock-recalls.
• Generates APQRs KPIs and slides/minutes for local management reviews.
• Attend meetings on behalf of the QP.
• Issuance of QC related documentation.
• Maintenance of archive and associated documentation e-archive and logbooks

Qualifications skills and Experience: -

• Minimum: Bachelors degree (BSc) in sciences (preferred)
• QA duties in the pharmaceutical industry
• Sufficient training in GMP basics
• Minimum of 2 years of industry experience; vaccines Steriles and biological experience is preferable
• A commercial outlook with attention to detail
• Pro-active attitude towards assuring quality and compliance
• Ability to deal with working with several stakeholders and to remain calm under pressure
• Fluent in Dutch and English

About CSL Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

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