GDP Quality Manager (m/f/d)

REFERENCE NUMBER:

532644/1

MY DUTIES:

- Drive and ensure timely resolution of product quality & compliance issues in the assigned RDCs, in compliance to internal QMS and local regulatory requirements including complaints/ recalls, investigations and audit related
- Responsible for notification and escalation of severe GDP events to company 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 internal QMS.
- Ensure compliance to Falsified Medicines Directive of the RDC(s)
- Perform and/or support GDP Audits at RDCs.
- Represent the company during regulatory agency inspections at RDCs.
- Provide support for inspections at internal 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.
- Maintain strong collaboration with Supply Chain, Site Quality Organization, RDC related LOC Quality and internal project teams.
- Establish or support the establishment of Quality Agreements related to RDC’s
- Process and/or administrate Quality Assurance information in the company´s electronic systems e.g. SAP, JDE, EQMS, LEADs etc.

MY QUALIFICATIONS:

- Strong knowledge of regulations pertaining to GDP, distribution, warehousing and transportation in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements)
- Understanding of Commercial Quality requirements, including regional and in-country distribution, controlled substance compliance, supply chain quality, and local quality surveillance (re-turns, recalls, complaints).
- Understanding of quality and regulatory requirements and trends related to warehousing and distribution in Europe, Multiple countries, supply & distribution models, regulatory frameworks and diversity of products
- Scientific Degree (BSc, MSc)
- Profound experience in in the pharmaceutical industry including Quality Assurance, combined with a good knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements)
- Prior experience managing external GMP/GDP suppliers
- Risk identification, evaluation and management
- Fluent in written and spoken English

MY BENEFITS:

- A very renowned company

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, 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 professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Selina Panhans

Reference number
532644/1

Contact
E-Mail: [email protected]