Manager Quality Assurance – CSV Specialist (m/f/d)

Greetings from AMW, a fast-growing bio-pharmaceutical company that’s been thriving for more than 15 years. Based out of Warngau (South of Munich), our team of >150 highly talented people develops, manufactures and commercializes medical innovation for international partners and patients all over the world. Our core strength lies in smart drug delivery systems, such as biodegradable implants for sustainable treatment of cancer tumours.

Just as smart but with an additional dash of drive and discovery is our day-to-day business: a state-of-the-art working environment, a friendly and collaborative working culture, efficient communication, and great opportunities for personal development are just some advantages you can expect. Join us and find out for yourself!

How you’ll make a positive impact

  • You will support our IT department in the creation of change control requests – particularly with regard to data integrity and CSV – and work on the corresponding risk analyses.
  • You will also administer and update GMP documents and provide our specialist departments and IT with advice and support on all aspects of data integrity and quality-related issues relating to our software applications.
  • You pass on your specialist knowledge to our teams in training courses
  • You will be in close contact with our internal IT department and external software developers to ensure compliance with GMP regulations (e.g. update management and revalidation).
  • You will be involved in interdisciplinary projects for the introduction of new software and in computer system validation and ensure GMP compliance and data integrity in teamwork.
  • You also check various protocols and documents for software validation: from IQ to OQ to PQ, test plans and Requirement Traceability Matrix (RTM).
  • Last but not least, you present your topics at customer audits, inspections, etc.

Your recipe for success

  • Completed studies in computer science, natural sciences or engineering, alternatively training in IT or natural sciences, or a comparable qualification and many years of professional experience in the pharmaceutical industry
  • Routine in software administration and computer system validation, project experience in ERP, LIMS or EQMS implementation; very good knowledge of MS Office
  • Know-how on GMP guidelines, in particular qualification and validation in accordance with GAMP 5, Title 21 CFR (Part 11), EU GMP Annex 11 etc.
  • Enthusiasm for IT and pharmaceutical topics and interest in building up expertise in these areas and their interfaces
  • Good knowledge of German and English, both written and spoken
  • Personally, you will impress us with your independent and precise way of working, which you will bring to teamwork with motivation.

In return, we offer smart benefits

  • Paid vacation (32 days for full-time contracts)
  • An exciting job with impact to improves patients’ health within a rapidly growing, international pharmaceutical company
  • A friendly work environment with flat hierarchy, quick decision processes, and a great company culture based on mutual respect and appreciation
  • Personalized career development programs
  • Company supported pension scheme
  • Job bike
  • EGYM Wellpass membership for sport and leisure activities
  • An assortment of fresh fruit and discounts on fresh, healthy lunch meals
  • Bicycle parking spaces
  • An attractive location in greater Munich with plenty of recreational opportunities in beautiful nature close to the Alps, together with a rich cultural choice and excellent infrastructure for (international) travel.

Ready to make a difference?

If so, we would like to hear from you! Simply email us your application (including cover letter, resume, and most recent references) to bewerbungen@a-m-w.eu.

Our current privacy policy can be found at https://a-m-w.eu/datenschutz/.

If you have any questions in advance, please contact our Business Support HR, Ms. Stefanie Lang, at 08024 470999-24.

Your route forward:

If you meet the requirements, our next step will be a call in Microsoft Teams. A second follow-up interview will be scheduled on-site if you (and we) feel it’s a good fit. And finally, step three (if all parties are on board) will be your AMW starting date.

AMW GmbH
Birkerfeld 11
83627 Warngau
Germany

We look forward to reaching new heights with you as part of the team. Hope to see you soon!

More about career at AMW