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QA Specialist

Company: Multination Biopharmaceutical organization
Location: Amsterdam Area
Starting date: January 2022

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer

Organization

Our client is at the forefront of immunotherapy and engineered T cell therapy. They are helping change the paradigm of cancer treatment and are revolutionizing individually tailored treatments. That means a fast-moving and constantly changing environment, where discoveries are made every day. We’re currently seeking to recruit highly motivated talents for different position to be part of the exciting journey in the development of innovative cancer immunotherapies and their translation into the treatment of patients with cancer.

 

Responsibilities:
As QA Specialist you will be supporting our efforts in the exciting area of CAR-T cell therapy. You will work as part of the disposition team to assist with the preparation of binders for QP release. You will be compiling the Final Product binders and performing review of various GMP documentation. Your responsibilities amongst others will be:

• Performs a wide variety of QA activities to ensure compliance with applicable regulatory requirements and procedures.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs),
• Reviews manufacturing, environmental monitoring and quality control data for in process and finished products.
• Compile final product binders for the QP release and perform QA disposition
• Contribute to the Quality on the floor processes, including GEMBA walks and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), and procedures.
• Conducts or acts as a coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products and performs QA review and approval of complex deviations and CAPA and contributes to cross functional investigations.
• Identifies deviations from approved procedures and processes, evaluates impact assessments and develops solutions for complex problems.
• Contributes to QA projects.
• Works on mid complex, non-routine projects/assignments where analysis of situation or data requires a review of identifiable factors.

Requirements:
We are seeking a highly motivated individual which likes to join our international QA Operations Disposition tam. The ideal candidate for this position is flexible, has great communication skills and feels comfortable challenging existing processes. This person has a critical eye and enjoys review work and daily interaction with QPs.

Education and experience:
• 4+ years of experience in a GMP environment and a BSc degree OR
• 2+ years of experience in a GMP environment related and MS (Master in Science).
• Prior experience in pharmaceutical industry or similar bio industry is preferred.

Interested?

If you are interested in this position, please apply or email met at s.vanderkleij@sire-search.com