QA - QA Expert
1 maand geleden
Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.
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 thus 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. lts four dedicated and fast-growing production sites are currently 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 GMPcompliant 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) QA - QA Expert
For more detailed information please feel free to contact Mrs. Peggy Engels, tel. 20 .
Please note: Agency acquisition to this vacancy is not appreciated.
Job responsibilities:
Participates in research and corrective actions regarding quality issues as requested by QA leadership; Coordinates the internal audits program; Conducts internal audits and formulates the follow-up in collaboration with those involved departments; Coordinates and implements the supplier qualification program in collaboration with the global organization; Coordinates external audits; Participates in audits and inspections of suppliers, customers and government agencies; Investigates reported deviations following a quality issue within production or QC. Coordinates follow-up; Coordinates the handling of customer complaints; Assists in the preparation of annual reports and provides statistical overviews of release data for the actual release; Trainer coach for new colleagues; Participates in special interdisciplinary task groups where QA input is desired; Supports QA management with regard to all developments in the field of quality, GMP and legal guidelines and plays an important role in the further and broader integration of quality into the company; Participates in special interdisciplinary task groups where QA input is desired; Supports QA management with regard to all developments in the field of quality, GMP and legal guidelines and plays an important role in the further and broader integration of quality into the company; Provides GMP (related) training within and outside the QA department.Qualifications required:
Knowledge and experience in managing/supervising Contract Manufacturers is a pre; For the position of Quality Assurance Expert we require a minimum of education of Bachelor degree in the orientation of Analytical Chemistry, (Micro)Biology, Biochemistry of Pharmaceutical Sciences; A minimum of 5 years experience in the pharmaceutical industry, preferably in QA; Excellent verbal and written communication skills; Ability to work with tight deadlines and handle multiple tasks; Computer fluency in MS Office, e.g. Word, Excel, PowerPoint. Knowledge of Veeva and SAP is a plus; Experience with FDA compliance is a plus; Profound knowledge of Dutch and English language, verbal and written; You reside in and are 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 online learning platform GoodHabitzAs 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
Reference Code:
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