QC Manager

CPL

Galway

QC Manager. The Role: Co-ordinates and manage all analytical staff and activities within the QC laboratory ensuring that all activities are carried out in a timely manner to meet company objectives and relevant key performance indicators. Manage and co-ordination of QC sampling routines for API, Utilities and final product with preparation of relevant QC documentation including protocols, reports, analytical data sheets, SOP’s, change controls, deviations and IRF’s. Review and approve departmental validation protocols, reports , including filled products, raw material and stability analytical data sheets. Review and approve ono-chromatographic and chromatographic data . Co-ordinate and manage any laboratory investigations and approve any retesting required. Ensure that they are documented correctly and closed out in a timely manner. Manage the stability testing program, ensuring any issues are promptly communicated. Manage the department purchase of equipment and materials and ensure availability of all materials required for testing. Manage and co-ordinate with Engineering and external instrument calibration/maintenance companies to maintain QC instrument calibration and maintenance to specified schedules. Manage the investigation and documentation of any retesting in the QC laboratory. Manage contract laboratory testing laboratories, ensuring compliance to GLP and agreed testing deadlines and costs. Adhere to all company and legislative EHS requirements. Support and implements EHS programmes and initiatives. Perform other duties as assigned. Crteria for role: Make Our Values Your Values. Minimum of a Scientific Bachelor’s degree (preferably Chemistry. 5+ years’ experience of sterile products in a pharmaceutical company. Must possess process and manufacturing knowledge of injectable processes (Aseptic and TS. Capability to manage team, set clear goals, communicate clearly and ensure progression to completion. Development and training of team members. Management of resources and budgets. Excellent communication skills (verbal and written. Proficiency in speaking, comprehending, reading and writing English is required. Interested in hearing more about this opportunity? contact Annette Murphy on 091 507515 or email your CV in confidence to annette.murphy@cpl.ie. This job originally appeared on RecruitIreland.com.

2614 days ago