Production Quality Officer (f/m/d) Job Details | Wacker Chemie AG We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser’s local storage. This includes cookies necessary for the website's operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve website's performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. 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Country/Region All City All Functional Area All Career Level All Employment type All Clear Select how often (in days) to receive an alert: Create Alert × Select how often (in days) to receive an alert: Apply now » Apply now + Start apply with LinkedIn + Apply Now Start + Please wait... Date: Oct 24, 2024 Location: Amsterdam Company: Wacker Biotech B.V. 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 100 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 inAmsterdam, we are looking for you as a(n)Production Quality Officer (f/m/d) For more detailed information please feel free to contact Mrs. Peggy Engels, tel. 0031 (0)20 7503 675. Please note: Agency acquisition to this vacancy is not appreciated. Job responsibilities: + You review batch documents and all other relevant documents from the production departments. You ensure in collaboration with the responsible employees that errors in the documentation are corrected; + You ensure strict compliance with GMP procedures within Production. Check compliance with GMP procedures (for example 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 Production input is desired; + You ensure correct administration (Trackwise) with regards to production-related Changes/Deviations, training courses and CAPAs; + You support Production 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 request 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 pre; + 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 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! Reference Code:28030