Regional Gdp Quality Lead

vor 2 Wochen


Zurich, Schweiz Hays Vollzeit

**My duties**
- Drive and ensure timely resolution of product quality & compliance issues in the assigned RDCs, in compliance to QMS and local regulatory requirements including complaints/ recalls, investigations and audit related
- Responsible for notification and escalation of severe GDP events to management
- Drives risks identification and mitigation for processes linked to and established at the RDCs.
- Ensure compliance to change management requirements at the RDCs and adequate translation into the QMS
- Ensure compliance to Falsified Medicines Directive of the RDC(s)
- Perform and/or support GDP Audits at RDCs
- Represents during regulatory agency inspections at RDCs. Provides support for inspections at manufacturing sites related to questions for RDC
- Evaluate the level of GMP/GDP compliance and risks for products managed by RDCs in the region through key performance indicators/quality performance indicators and drives the implementation of improvement activities
- Participate in supporting recall activities, as needed
- Maintain strong collaboration with Supply Chain, Site Quality Organization, RDC related LOC Quality and project teams
- Establish or support the establishment of Quality Agreements related to RDC’s
- Process and/or administrate Quality Assurance information in electronical systems e.g. SAP, JDE, EQMS, LEADs and other electronic systems

**My qualifications**
- Scientific Degree
- Experience in the pharmaceutical industry including Quality Assurance, combined with a profound knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements)
- Attention to details, ability to review & managing documentation (including transport temperature records, shipping documents, and related GDP documents/ records etc.)
- Experience managing external GMP/GDP suppliers
- Skilled at leading GMP/GDP audits
- Profound English knowledge

**My benefits**
- Internationalpharma company
- Domestic and international travel will be required (up to 10%)

**About Hays**
- With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages - completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.**My contact at Hays**

**Reference number**
649073/1

**Contact**
Phone:
+41 44 225 50 00


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