Qc Analyst
il y a 4 semaines
QC ANALYST
- Pharma- GhentWHAT 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 immunology.
The QC Analyst will be responsible for performing QC testing related to the manufacturing of cell therapy products (clinical trials and commercial operations) with focus on a GMP environment.
Main responsibilities include:
- QC testing related to the manufacturing for clinical trials and commercial operation in a GMP cleanroom environment
- Ensure testing is completed in compliance with all procedures, standards and GMP regulations.
- Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to GMP facility to manufacture products.
- Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
- Perform peer review/approval of laboratory data
- Utilize electronic systems (LIMS) for execution and documentation of testing.
- Create, review and approve relevant QC documents, SOP’s and WI’s.
- Perform tasks in a manner consistent with the safety policies, quality systems and GMP requirements
REQUIRED COMPETENCES & SKILLS
- Bachelor’s Degree in Science, Engineering or equivalent or relevant years of experience within the pharmaceutical industry
- 1-2 years relevant work experience is required, preferably within quality assurance, manufacturing compliance or clinical quality
- Knowledge of aseptic processing in ISO 5 clean room and biosafety cabinets
- Knowledge of GMP and FDA/EU regulations related to manufacturing of cell-based products
- Experience in a Quality Control
- Detailed knowledge of cell-based QC test methods and related equipment is preferred
- Great attention to detail and structured/organised mindset to follow procedures
- Capable of working in a team environment with a positive attitude
- Experience with team-based collaborations
- Good written and verbal communication skills, ability to speak and interact with inspectors
- Problem-solving mindset
- This position may require up to 10% domestic or international travel as business demands
- 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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