Role DescriptionA challenging position in an innovative, fast growing, biotechnology company. Working in a fast-paced dynamic environment brings the opportunity to make your own mark within the organization.
Responsibilities- Responsible for correct use of QA systems, SOP’s and Procedures. - Responsible for reviewing master documents and batch documentation. - Responsible for performing internal and external audits autonomously. - Perform batch and (QC) test record review, including approval. - Write, review and approve applicable controlled documentation, eg. batch records, (audit) reports, protocols and other cGxP QMS documentation - Performing initiation, review and assessment of deviations, change control requests, CAPA’s, OOS and other QMS input. - Back up for QA Manager.
Requirements- B.Sc./ M.Sc. in Biotechnology, Chemistry or equivalent field. - Minimal 6 years of experience in a similar role in an international working environment and minimal 8 years of experience in pharmaceutical industry. - Minimal 2 years of experience in auditing pharmaceutical and laboratory organisations. - Experience in GMP production/ Quality Control. - Excellent understanding and knowledge of cGMP/ ICH guidelines for both EU and USA. - Understanding of state-of-the-art practice in the cell therapy field. - Experience with competent authority inspections
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.