Pharmazeut, Chemiker – QA Management, GMP (m/w/d) (Miesbach)

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. 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)
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! Please send us your
complete application including your salary expectations and
termination notice – preferably via e-mail into one PDF document at
personal.hr@acino.swiss We are looking forward to the opportunity
to get to know you.