Our client, a biotech company, based in Zwijnaarde, is a global biotechnology company bringing the innovative cell therapy to Ghent. With this, the team makes a daily difference in the lives of many patients suffering from cancer and other life-threatening diseases.
They are currently in a phase of strong growth and are looking for motivated and dedicated team members.
They are currently in a phase of strong growth and are looking for motivated and dedicated team members.
YOUNG GRADUATES - BACHELOR IN BIOCHEMISTRY, CHEMISTRY OR BIOLOGY | QC Analyst
Functieomschrijving
For our client in Zwijnaarde, we are looking for a QC Analyst.
Your tasks and responsabilities include:
Your tasks and responsabilities include:
- Responsible for the completion of QC testing related to the manufacturing of autologous products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
- Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
- Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP 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 cGMP requirements.
- Other duties will be assigned, as necessary
Profiel
- Education:
You have you have a Bachelor's degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical
industry.
Capabilities, Knowledge, and skills:
You have you have a Bachelor's degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical
industry.
Capabilities, Knowledge, and skills:
- Experience in a Quality Control setting is preferred.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
- Knowledge of Good Tissue Practices is required.
- Detailed knowledge of QC test methods and related equipment is preferred
- Excellent written and oral communication skill are required
- Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
- Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Comfortable with speaking and interacting with inspectors.
Aanbod
- You will join an exciting pharmaceutical company with opportunities for growth.
- You will work within a strong and respectful diverse team where everyone is welcome.
- Your Team is a diverse team who speaks Dutch or English
- You will receive an attractive salary package including meal vouchers and eco vouchers.
- Hospitalisation insurance, group insurance and bonus complete the salary package.
- You will work in a 2-shift system (6 am - 4 pm / 2 pm - 00 am) in a regime in which you work 4 days, have 4 days off, etc. This gives you a nice balance between Work and Personal life
- You will work in an environment where loyalty and team spirit
Praktische informatie
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