Global QA Compliance Manager
vor 3 Wochen
Global QA Compliance Manager (w/m/d)
München, 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.
Global QA Compliance Manager (w/m/d)
Major Accountabilities:
Plan, lead, conduct, report and follow up of Quality GMP/GDP audits at ACINO manufacturing sites and ACINO local/regional organizations as well as external aseptic and non-sterile and other GMP/GDP service providers according to ACINO procedures. Identify areas of risk and provide independent assessments on impact of audited activities. Assure permanent transfer of best practice identified during the audit into ACINO QMS system. Support the strategic development of an effective global risk-based audit strategy and program. Monitor the global annual external and internal audit plan. Maintain current knowledge of regulations, standards, and guidance documents. Lead the Global Escalation Management System within ACINO. Support the Inspection Readiness program at ACINO Sites/offices. Support maintenance and improvements of computerized Quality Audit Tools (Trackwise Establish and maintain global Directives and SOPs relevant for external and internal auditing. Understand quality by design and actively contribute to drive the improvement of the auditing process. Support the internal and external auditor qualification program. Identify and report best practices and lessons learned to support development/training of internal GMP/GDP auditors.Your Profile:
At least 10 years’ experience in the Pharmaceutical Industry; at least 3 years of auditing experience, Solid GMP/GDP auditing experience related to GMP, GDP or ISO for Pharma, preferable with experience in sterile manufacturing leading audits. Strong knowledge and understanding of the EU, FDA, PICs, WHO and other relevant GMP, GDP and ICH guidelines and regulations, including ISO 9001 and ISO 13485. Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems. General knowledge of technical, chemical and pharmaceutical processes, validation procedures and analytical methodology, Capable of understanding and overcoming different cultural and language obstacles to provide solution that satisfy corporate, regional and local objectives. Self-motivation, flexibility and a high level of individual responsibility. Eagerness to learn and continuously improve.We offer a very attractive working environment within a highly motivated team with excellent working conditions. You can expect the following benefits:
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.
Note that only direct applications via our HR system (follow the link above) will be considered.
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