Wacker Biotech, as part of WACKER, is a leading global biotechnology organization specializing in the production of biopharmaceuticals. The company has outstanding technologies for the rapid, efficient, and cost-effective production of therapeutic proteins for clinical and commercial supply. Currently, it is the biggest dedicated microbial Contract Development & Manufacturing Organization (CDMO) in the world. Its four dedicated and fast-growing production sites are based in Germany (Halle and Jena), The Netherlands (Amsterdam), and The United States (San Diego, CA). At our Amsterdam-based center, Wacker Biotech B.V. Focuses on the GMP-compliant microbial-based production of recombinant proteins, vaccines, and live microbials as drug substance and drug product.
To strengthen our team in Amsterdam, we are looking for you as a(n) QC - Quality Officer.
Job responsibilities:
- You review test-related documents and all other relevant documents from the Quality Control departments. You ensure, in collaboration with the responsible employees, that errors in the documentation are corrected.
- You ensure strict compliance with GMP procedures within QC. Check compliance with GMP procedures (e.g., logbooks, order, and tidiness, documentation, etc.).
- You ensure operational compliance and progress by frequent presence on the shop floor and by means of (random) checks. You identify and initiate corrective measures where necessary and provide immediate feedback on this.
- You participate in investigations and corrective actions related to quality issues.
- You participate in internal GMP inspections and customer inspections.
- You perform spot audits and formulate the CAPA in collaboration with the QA department.
- You participate in special interdisciplinary task groups where QC input is desired.
- You ensure correct administration (Trackwise) regarding QC-related Changes/Deviations, training courses, and CAPAs.
- You support QC management with regards to all developments in the field of quality, GMP, and legal guidelines, and you play an important role in further and broader integration of quality in the company.
Qualifications required:
- University or Bachelor level with sufficient relevant experience.
- Experience in working under GMP guidelines in the bio- or pharmaceutical industry.
- Experience in quality investigations, implementation of change requests, and execution of corrective quality actions.
- Experience in driving quality improvements in an operational pharmaceutical organization.
- Experience with internal and external audits.
- Experience with working in project teams/organizations is a plus.
- Good communication skills on different levels of organizations.
- Good English (and preferably Dutch) language skills.
- Quality awareness, flexible, and proactive.
- Residing and eligible to work in the Netherlands (valid work permit).
What do we offer?
- Employment: A challenging and international position in a professional and informal working environment.
- Compensation: Attractive salary, holiday allowance, home-office travel allowance, participation in the company's success, subsidized pension plan.
- Work-life balance: Flexible working hours (where possible), 30 days of vacation.
- Versatile development opportunities: Support for professional development, access to the online learning platform GoodHabitz.
As an international company, we welcome the diversity of people. We consciously promote equal opportunities and a diverse, inclusive culture in our teams - this is what makes us successful.
We look forward to receiving your application!
#J-18808-Ljbffr