Job Description

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

Miesbach, Germany

Acino AG, based in Miesbach (moving to Munich in the first half of 2020), 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 the quality assurance department.

Responsibilities:

  • Organization of supplier and service provider qualification
  • Coordination, organization and execution of Audits
  • Creation, review and management of Quality Agreements
  • Processing, coordination and tracking of Deviations and CAPAs
  • Organization of trainings and SOP management
  • Creation of PQRs and Quality KPIs
  • Review of relevant GMP and registration documents (e.g. Batch Record Review)
  • Maintenance and further development of Quality Assurance systems
  • Assisting the processing of Change Requests and Complaints
  • Participation in Customer audits and Authority inspections as well as tracking of observations
  • Cooperation and takeover of projects
  • Communication and cooperation with suppliers and service providers
  • If applicable substitution of the Qualified Person (i.e. batch release and rejection as well as approval of quality-relevant documents)

Skills:

  • University degree in natural sciences (e.g. pharmacy, chemistry, biology)
  • Several years of professional experience in the industrial manufacture and testing of pharmaceuticals (quality control, quality assurance, production and/or development)
  • Required qualification as a Qualified Person according to § 15 AMG desirable
  • Excellent knowledge of Good Manufacturing Practices (GMP)
  • Experience as an auditor
  • Solid knowledge of MS Office applications
  • Strong communication skills and ability to work in a team
  • Reliable and careful way of working
  • Ability to work independently
  • Excellent written and verbal communication skills. Fluent in German & English (written and oral) is a must; any further languages are an advantage

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 this sounds exciting, we look forward to hearing from you!

Apply & Further Information

To apply we invite you to send your application along with all pertinent documents – preferably via e-mail in one PDF document – to our HR team through the email listed below. The team is also happy to respond to any questions about the role or Acino, that you might have.

personal.hr@acino.swiss

We are looking forward to hearing from you. Only direct applications are considered.

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