Quality Control Manager | Collins McNicholas

Quality Control Manager

  • Reference: GY43934
  • Job Type: Permanent
  • Location: Galway, Galway City, Mayo
  • Category: Science, Pharmaceutical & Food

Responsibilities 

  • 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.

  

Qualifications

 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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