Our client is a biopharmaceutical company engaged in the development of innovative cancer immunotherapy and they are immediately looking for QA Specialist (Monday-Friday, 40 hours) in Hoofddorp.
All applicants MUST have full legal authorization to work in the EU region independently and be fluent in both spoken and written English language.
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.
* 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.
The ideal candidate
We are seeking a highly motivated individual which likes to join the international QA Operations Disposition team. 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.
What do we offer
· Temporary agency contract via Kelly for 40 hours duration 6 months with possible extension via Kelly
· Start date: ASAP
· Salary indication depending on experience: € 4666-€ 4700 gross per month based on 40 hours; excluding travel allowance up to a maximum of € 338 per month
Please do contact Marcella Henryati, Recruitment Consultant
When interested please apply with your English resume on our website: www.kellyservices.nl
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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.