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 Rutger Koning.