QA Batch Release

Ghent | Belgium | Quality Assurance | GMP | Batch Record | GDP & MES | Dutch & English

Your new company

Our client, in Belgium, is a global biotechnology company dedicated to treating and curing life-threatening diseases. They develop cell therapies across a diverse range of technology platforms, including autologous and allogenic chimeric antigen receptor T – cell and NK cell – based immunotherapy. They are committed to improving the lives of patients worldwide at multiple sites and their goal is to reimagine healthcare and to deliver transformative treatments in the fields of oncology and cell therapy.

Your new role

The QA Release Specialist is responsible for providing quality oversight over the production of a personalised cell therapy to support both clinical and commercial requirements in a sterile GMP environment.
This includes paper/electronic batch record reviews related to the manufacturing of viral vector and autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Job duties are performed within a team according to an assigned production shift schedule.

Main Responsibilities:

  • Review documentation for all manufacturing activity execution in accordance with good documentation practices.
  • Independently executes paper/electronic batch record review associated with commercial, development, and engineering production.
  • Perform duties under limited supervision and according to standard operating and manufacturing procedures.
  • Contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines.
  • Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
  • Implements appropriate corrective and preventive actions by investigating non-conformances in a timely manner.
  • Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

What you'll need to succeed

A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required with a minimum of 4 years of relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
You have extensive knowledge of GMP regulations and FDA/EU guidance related to manufacturing cell-based products. You have strong communication skills in English and Dutch with attention to detail. You can process complex information to make critical decisions and be flexible to work on weekends as needed.

What you'll get in return

Our client in Belgium is offering contracts directly, so you will sign your contract with them. After successful interview rounds and offer acceptance, you will get a meaningful job that contributes directly to the well-being of patients with an excellent work-life balance. You’ll be part of a supportive and innovative working environment that encourages learning personal development. Alongside that, you will get the chance to work in a multinational setting with an open – ended contract and an attractive salary. Other secondary benefits include additional statutory holidays, meal vouchers, group and hospitalisation insurance, an end-of-year bonus and a performance bonus.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.


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Overzicht

Contractvorm
Permanent
Branche
Pharmaceutisch
Locatie
NETHERLANDS
Vakgebied
Life Sciences
Salaris
Competitive Salary + Secondary Benefits
Referentie:
1048671

Spreek met een consultant

Spreek met Tom Murphy, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam
Hays Amsterdam, Rijnsburgstraat 9-11

Telefoonnummer: 0628837634

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