Job Description

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Senior QA Manager (m/f/d)

Munich, Germany

Acino AG, based in Munich, is part of the Acino Group, a Swiss pharmaceutical company and a leader in advanced drug delivery technologies with its headquarters in Zurich.

Acino out-licenses its own products and manufactures third party products mainly for the European market. In its commercial operations, Acino has a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America. We operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

We are constantly expanding our market position with a future-oriented international business strategy. Therefore, we are looking for a dedicated and motivated person to strengthen our team in Munich, Germany.

Senior QA Manager 100% (m/f/d)

Major Accountabilities:

  • Quality Due Diligence of new products and support of launches
  • Qualification of Contract Manufacturing Organizations (CMOs) and service providers
  • Management of the external Audit Program, including performing and follow up of audits at CMOs and Service Providers
  • PQR Management
  • Management of Quality Agreements
  • Communication with suppliers, CMOs and service providers
  • Compliance Ambassador and support with Regulatory Compliance
  • Active participation in authority inspections and customer audits as well as follow-up of observations
  • Document Management, including support in the maintenance and continuous improvement of the Quality Management System (e.g. SOPs, certificates of analysis, specifications, etc.) including the system for archiving of documents and filing of documents
  • Management of GxP Training
  • Training of Jr QA Managers and interns
  • Support the Qualified Person during batch release
  • Review and approval of GMP and GDP related documents (e.g. MBRs, Certificates of Analysis)
  • Support the Responsible Person in Management of Distributors
  • Support in the storage and management of retained samples
  • Support in providing monthly Metrics
  • Support in processing and follow-up of change controls, complaints, deviations and CAPAs
  • Support in projects
  • Support in administrative and organizational activities

Your Profile:

  • University degree in natural sciences (e.g. pharmacy, chemistry, biology)
  • Several years of experience in the pharmaceutical industry (QA, production and/or Quality Control)
  • Knowledge of Good Manufacturing Practices and legislation for medicinal products (national, EU and international like ICH, WHO and PIC/S)
  • Excellent analytical skills
  • Good knowledge of MS-Office applications
  • Ability to communicate and work in a team
  • Reliable, independent and accurate way of working
  • Very good knowledge of German and English (written and spoken)

We offer a very attractive working environment within a highly motivated team with excellent working conditions. You can expect the following benefits:

  • A job in a crisis-proof pharmaceutical company
  • An international working environment in a constantly growing company
  • A quality and customer-oriented environment
  • A motivated, agile and service-oriented team
  • Interesting and highly diversified tasks that provide a broad basis for your future career in the pharmaceutical industry
  • Attractive salary
  • Flexible working hours (possibility of home office)
  • This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If you are interested in this role we are looking forward to hearing from you.

Please apply via our HR system here.

Note that only direct applications via our HR system (follow the link above) will be considered.

Further Information

Our team is happy to respond to any questions about the role or Acino you may have:

personal.hr@acino.swiss

We are looking forward to hearing from you.

Only direct applications are considered.

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