About this role
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, CAPA’s, 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 APQR’s, KPI’s 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 of 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. 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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
Other facts
About CSL
CSL Plasma is one of the world’s largest collectors of human plasma. We are committed to excellence and innovation in everything we do. Our work ensures that tens of thousands of people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because people’s lives depend on us. See our community guidelines: https://bit.ly/2IApjpz.
Supported by parent company CSL Behring, the global leader in plasma protein biotherapeutics, CSL Plasma has more than 280 plasma collection centers globally. CSL Plasma also has a state-of-the-art testing laboratory that features some of the most advanced technology, instrumentation and automation in the field; two logistics centers, one in Dallas and one in Indianapolis. Our corporate headquarters in Boca Raton, Florida.
Our U.S. plasma collection centers are committed to the highest standards of quality and safety. When you donate, you give a valuable gift to those who require plasma-derived therapies to live healthier lives.
The CSL Group has a combined heritage of outstanding contribution to medicine and human health with more than 100 years experience in the development and manufacture of vaccines and plasma protein biotherapies.
With major facilities in Australia, Germany, Switzerland and the US, CSL has over 30,000 employees working in more than 35 countries. See our community guidelines: https://bit.ly/3QZbZeZ
What you'll do
- The QA associate will support the QP on all QA activities for the Amsterdam site, including commercial and clinical batch release activities. Responsibilities also include reviewing and approving validation protocols, managing deviations, and supporting audits and inspections.
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