This multinational Pharma organisation is going through exciting growth in the Cork site. They are in the process of hiring 2 laboratory leaders across both IPC and QC.
Duties and Responsibilities:
•Participate in identifying resource requirements (personnel, equipment and facilities) for the IPC laboratory. Participate in the recruitment of personnel for the laboratory and develop the strengths/talent of team members.
•Ensure that group and individual training requirements are met.
•Liaise with the Operations team and other customers to ensure all lab testing requirements are met.
•Highlight operational issues to the quality leadership team.
•Liaise with internal customers to establish workloads, agree timelines (where appropriate) and identify priorities. Manage and prioritise the activities of the IPC laboratory such that customer, team and individual objectives are met. Ensure that Visual Workplace metrics and Performance Management for the laboratory are achieved.
•Provide management with regular communications regarding IPC Visual Workplace metrics, Performance Management, specific project work or other initiatives within the IPC group.
•Ensure calibration of equipment is carried out as per the documented schedule.
•Ensure that environmental water testing is carried out as per defined schedule.
•Ensure completion of any corrective actions assigned to the laboratory as part of a level 2 audit.
•Carry out monthly review of Laboratory Investigation Reports for the laboratory.
•Monitor rejection of invalid data reports on a monthly basis.
•Ensure there is a process for the Review of Cleaning Batch Records, Solvent Recovery Batch Records as required.
•Maintain Laboratory Raw Data books in compliance with GMP requirements.
•Provide oversight and review for laboratory investigations.
•Review and approval of change controls
•Execute Level 1 and Level 2 audits as required.
•Lead the role out of the RCA tool to the laboratories. The role should be able to demonstrate use of other OE tools in problem solving.
•Minimum of BSc Hons Degree Science, and/or higher degree
•Knowledge of and participation in inspections, audits and reviews of operations and processes is required.
•Knowledge of SAP, Empower and LIFT IT systems
•Detailed knowledge of the cGMP requirements relevant to the role and understand the GQMPs and GQPs that relate to the role.
•Relevant training in auditing.
•Relevant training on QMS standards.
•Working knowledge of CAPA’s, project planning and management, managing groups, running QIPs.
•GMP competent as applied to an analytical laboratory
•Previous experience within the pharmaceutical environment is preferred.
For a confidential discussion and more information on the role, please contact Rory Walsh.