YOUNG GRADUATES - BACHELOR IN BIOCHEMISTRY, CHEMISTRY OR BIOLOGY | QC Analyst

Description de fonction

For our client in Zwijnaarde, we are looking for a QC Analyst. 

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

Information

Our client, a biotech Information, based in Zwijnaarde, is a global biotechnology Information 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.

Profil

- 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:

• 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.

Offre

• You will join an exciting pharmaceutical Information 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