Gmp Lead
CPL
Dublin West
My client, a Dublin based Pharmaceutical company now have a new requirement for a GMP Lead. This is a permanent position. Role & Responsibilities: Overall objective is to manage, support and drive improvements in all aspects of production GMP/GDocP. The ideal candidate will have a third level qualification (NFQ Level 8 or higher) in a relevant discipline, and/or a minimum of 5 years relevant experience in the pharmaceutical industry. Experience in preparing for and participating in regulatory and internal audits are required. A full understanding of GMP regulations and GDocP standards are required. Key Tasks: Manage and organise for success a team of production support staff who will play an essential part in maintaining GMP/GDocP within production. Communicate effectively to direct reports to ensure that their goals are clear, understood and linked to day to day production support activities. Improve on current GMP/GDocP standards in line with industry best practice and regulations. Ensure that GMP/GDocP vulnerabilities are identified in each production business unit and remediated. Continuously strive to improve the standards within production and actively striving for a state of audit readiness. Support the fostering of a right-first-time culture within production. Liaise closely with the Production Business Units, Quality, Technical Services, CI and Logistics functions to meet departmental/site goals. Ensure visibility of production GMP KPIs, review these KPIs regularly and take the required action to continually improve on these KPIs. Drive continuous improvement through structured problem solving. Support/Lead/Facilitate problem solving initiatives and engage GMP and support personnel in problem solving so that they actively support activities that improve performance. Write reports as required and according to relevant SOPs. For full details contact Tina at tdunne@thornshaw.com or call +353 1 2784671. Log on to www.thornshaw.com. This job originally appeared on RecruitIreland.com.
1834 days ago