Cache of job #13889835

Job Title

EU Head Of Commercial Quality Operations

Employer

Hrm

Location

Dublin

Description

This leading pharma group employs over 10,000 staff globally with over 25 manufacturing operations at 18 sites on six continents. A global supplier of branded and generic pharmaceutical products as well as infant nutritional and consumer healthcare products in selected territories. This organisation boasts a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality, effective, affordable medicines and products. Reporting directly to the Head of Technical Operations Europe, the Head of EU Quality Operations will head up all commercial quality for the business within the EU. The Position: Provides direction and leadership to direct reports and other key QA Managers to enhance compliance of GMP/GDP systems in Europe region. Assures that the QA Operations department complies with company policies and the QMS. Ensures that all direct reports are trained and that continuous training programs are maintained. Is accountable in conjunction with the Responsible Person (RP GDP) and the Qualified Person (QP GMP) for the overall site compliance in terms of HPRA requirements, company policies, procedures and all other applicable regulations and guidelines. Reviews/Approves Standard Operating Procedures and all master quality documents in relation to the operation of the GDP/GMP licences in the region. Attends the periodical Quality Management Review meetings for monitoring trends in quality parameters, Deviation and Change Control; presenting recommendations to the management to maintain process under control and/or to further improve the process. Presents regularly performance reviews against measures relating to the Quality objectives at periodically held Quality Operations meetings. Ensures self-inspections are performed in adherence with an approved schedule at defined intervals and that necessary corrective actions are implemented. Holds overall responsibility for reporting and investigation of non-conformances and identification of CAPAs for continuous improvement. Elevates any serious quality issues to Group Quality for action. Ensures that returns handling, temperature excursions management, complaints handling, stock transfers/release are dealt with efficiently and effectively and in accordance with the Quality Technical Agreements. Ensures batch release/certification, deviation management, annual product review, dossier-, PIF-review, change control, LPC management & coordination are dealt with efficiently and effectively and in accordance with the Quality Technical Agreements. Assists in recall activities as required on behalf of the Marketing authorization holder and notifications to Health authorities. Approves change requests, risk assessments and action plans. Keeps up to date with any changes in the legislation and work seamlessly with Group personnel as it relates to Quality requirements for Europe. The Person: 10 years experience in Pharmaceutical Industry. Excellent understanding of GDP and GMP regulations, Quality Assurance and Risk Management. Pharmacist or BSc in Analytical Science. QP qualification would be advantageous. Ability to work in a complex matrix team environment and with both internal and external partners. To learn more apply online or contact Shane Browne at HRM on 353 1 632 1865. This job originally appeared on RecruitIreland.com.

Date Added

2163 days ago

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