For one of our clients, leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, we are urgently looking for a quality control lab support Expert.
In accordance with the manager, you will:
- Organize sample management for raw materials, IPC and finished product. - Manage GMP documentation such as SOPs, batch records, certificate of analysis, specifications, (writing and reviewing) to ensure traceability of analyses performed in the QC labs. - Review analytical data in analytical batch records and scientific reports. - Follow-up deviations, CAPA plans and change controls. - Ensure follow-up of qualification of lab equipment. - Participate in investigation and lab improvement. - Manage contacts with customers or subcontract labs. - Organize purchase of reagents and disposables for laboratories. - Interact with R&D department to implement new methods in the QC laboratory: method improvement, analytical validation and transfer, documentation, etc. - Creation/update AMBR (analytical master batch record) - Creation/update specification sheet - Impact analysis in case of regulatory change (pharmacopea, USP, etc.)
- Bachelor or Master level in a scientific discipline (Chemistry, Biology, Biochemistry, Pharmacy). - Minimum 3-5 years experience working in a laboratory, preferentially in the pharmaceutical industry. - An experience in a QC/QA environment is an asset. - Good knowledge of physico-chemistry and/or microbiological analytical techniques. - Good knowledge of GMP regulations (US and EU) - Quality oriented, rigorous and well organized. - Team player - Good knowledge in French and English (oral and written)
Wat bieden wij?
- Defined career path and annual performance review and feedback process - Competitive contributory pension and benefits package all offered from day one of employment - 36 days¿ holiday + bank holidays