- Reference: GY43934
- Job Type: Permanent
- Location: Galway, Galway City, Mayo
- Category: Science, Pharmaceutical & Food
- 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.
Minimum qualifications and essential functions for this position:
- Minimum of a Scientific Bachelor’s degree (preferably Chemistry) with 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.
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