What You’ll Do
In this role you plan, schedule and conduct cGMP (i.e. API, starting materials, Food Dietary Supplement,) and ISO QMS audits (on-site, paper based, remote) at our suppliers and 3rd parties in Europe (mainly Germany and Switzerland) to ensure compliance to statutory requirements and QMS standards.
Your key responsibilities
- Plan individual assigned audits of suppliers, 3rd parties (contract laboratories, warehouses, toIlers, contract manufacturers etc.) in the region in cooperation with the stakeholders (site, purchasing, auditee)
- Conduct the onsite audit by leading interviews, reviewing onsite documentation, conducting site tours
- Familiarize with the applicable standards before the audit, like: (ISO 9001, ICH Q7, FSSC/ISO 22000, FAMI-QS, , EFfCI and others)
- Look for risks and vulnerabilities of processes and product failures and identifiy opportunities for preventive action
- Recommend changes to assure compliance with regulations/guidelines and to facilitate continuous improvement activity as necessary.
- Reporting and communication of outcome, coordination of follow ups
- Write the report and communicate the outcome to auditee and requesting DNP site
- During the audit process identify external quality management and GMP good practices for sharing with in the DNP organization
- Develop and maintain internal auditor training programs and tools
- Provide monthly performance data on Audit activities
- University degree in Chemistry or Life Science
- 3-5 years’ experience in Food and/or pharmaceutical manufacturing QA is required
- Broad knowledge of quality management
- Lead auditor certification by an internationally recognized organization
- Strong understanding of general management practices and processes.
- Knowledge in GMP for: Active Pharmaceutical Ingredients, Dietary Supplement, Pharmaceutical Excipient, Food, Feed,
- Travel readiness (min 50%) – Europe, mainly Germany, Switzerland
- English fluent, very good knowledge of German
The encouragement you need to develop and achieve your goals
Home office work policy and thus a hybrid workplace for your flexibility
Attractive benefits such as optional Klimaticket for whole Austria (after 6 months of employment) supported canteen, company sports programs, accident insurance for work and private incidents , fresh fruit and free drinks,
Ergonomic and state-of-the-art office equipment in sustainable, modern office buildings
State-of-the-art laboratory equipment in our research facilities
Parking available and public transport (city train Vienna – Tulln – Getzersdorf – St. Pölten) in close walking distance
The chance to shape DSM and its impact for years to come
Diverse employees who aren’t afraid to think outside of the box
What else is there to know?
Your place of work: Remote, Austria
Our recruitment processes
Interested in this position? Please apply on-line by uploading your resume in English via our career portal.
The procedure will generally be in line with the DSM application process outlined on the DSM career website. Due to privacy regulations, we can only actively interact with applications via our career portal.
Royal DSM is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as a qualified individual with a disability, or any other characteristic protected by law.
Royal DSM and its associated companies deliver annual net sales of about €10 billion with approximately 23,000 employees. The company is listed on Euronext. For more information about DSM see http://www.dsm.com