QA Release Specialist
il y a 2 jours
QA RELEASE SPECIALIST
- Biotech- GentWHAT IS OFFERED
Be part of an international and diverse team, whilst developing one of the breakthrough innovations within healthcare and technology.
This is a unique opportunity to have impact, write history and challenge yourself in a highly novel environment.
ABOUT THE COMPANY
MindCapture supports in the recruitment of this talent for a global biotech company that’s developing, manufacturing and commercializing new cell-based therapies to battle cancer with focus on personalized immunological therapies.
The **QA Release Specialist** is an exempt level position with responsibilities for providing quality oversight over the production of a personalized 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.
- Reviews 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.
- Performs 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.
REQUIRED COMPETENCES & SKILLS
- Bachelor’s Degree in Science, Engineering or equivalent or relevant years of experience within the pharmaceutical industry
- 3-5 years relevant work experience is required, preferably within aseptic manufacturing (quality assurance, manufacturing compliance, clinical quality, cell therapy, )
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
- Strong interpersonal and written/oral communication skills.
- Ability to quickly process complex information and often make critical decisions with limited information.
- Great attention to detail and ability to follow the procedures.
- Good written and verbal communication skills are required.
- Ability to collaborate well with stakeholders, customers and peers.
- Fluent in Dutch and English
**Important: this challenge is within a shift schedule, with the advantage of working 4 days per week (10 hours/day) with 4 days off. Shifts include routine weekend and evening work as required by the process. This shift system can help you avoid traffic and reduce time spend in the car.
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