Quality Manager GxP Computer Systems

Employer Information

Norbrook

E: human.resources@norbrook.co.uk

T: + 44 (0)28 3026 4435

W:

Job Overview
To lead compliance for Norbrook Laboratories Ltd in relation to GxP computer systems quality assurance. To ensure that all GxP computer systems in use at Norbrook Laboratories Ltd are identified, evaluated, validated, maintained and periodically assessed in accordance with cGMP and company procedures.

Main Activities/Tasks

  • Provide leadership and guidance to the company with respect to compliance of GxP computer systems quality assurance.
  • To conduct independent review of validation and qualification documentation for GxP computer systems. To ensure that an overall list of GxP computer systems exists and is maintained as current.
  • Accountable for scheduling, tracking, reporting and achieving project deadlines.
  • Provide expert input into the core aspects of Operations, Qualification and Validation SOPs with respect to GxP computer systems. Serve as a CSV representative for internal technical group discussions.
  • Mentor the Quality Systems Managers / Quality Assurance Officers as assigned and ensure that they are appropriately trained and performing their functions in relation to review of GxP Computer systems.
  • Attends departmental and team meetings focused on CSV activities and actively contribute to project teams.
  • Understanding and applying industry specific compliance standards/regulations to all Commissioning/Qualification activities for GxP computer systems.
  • Ensuring that planned periodic reviews of systems are performed and that implementation of any remedial actions necessary is planned and implemented.
  • To ensure that Health and Safety practices and procedures are followed in the incumbent’s area of responsibility.
  • Any other tasks as deemed necessary.

Essential Criteria:

  • Third level qualification in a scientific, information technology or engineering discipline with a strong information technology background.
  • Good working knowledge of current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
  • At least five years’ experience in the field of GxP computer systems quality assurance.

​​​​​​​Desirable Criteria:

  • Knowledge of Pharmaceutical product manufacturing and filling processes
  • Knowledge of Computer System GxP requirements including GAMP5 and 21CFR Part 11 requirements.
  • Knowledge of software coding, experience in the implementation of a risk based validation approach, experience with process control & building management systems.
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