Neuroplast BV, a Maastricht/Geleen based biotech company is looking for a
QUALITY ASSURANCE OFFICER (M/F)
The Quality Assurance Officer will be responsible for planning and execution of daily quality assurance activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility. You will be a critical part of a dynamic international biotech-company in the field of regenerative medicine.
- Plan and execute quality assurance activities (document management, batch records and label issuance, batch record review, equipment and supplier qualifications etc.) including documentation.
- Monitor compliance with all applicable GMP and safety standards.
- Support the Qualified Person in his role, including audits and quality training.
- Write, review and approve documentation (SOP's, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests). Handle, distribute and archive controlled documents.
- Prepare data for trending (QRB, Annual Product Review) and support internal and external audits.
Position requirements, and competences:
- Master of Science in Pharmacy/biotechnology, preferable PhD.
- Knowledge of GMP, and preferable experienced with cellular products.
- Fluent in English (verbal and written).
- Accurate, proactive, self-organized, flexible, attention to detail, team player.
- Demonstrates general knowledge of quality standards, methodologies and systems, and ISO standards.
- Proven ability to effectively participate in multi-disciplinary and multi-culture teams.
- Good understanding of European regulation (ATMP).
- Willing to participate in rotating shifts to assure 24h. availability at the site, together with QA colleagues.