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QC Analyst

1 month ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

External Job Description

Cpl, in partnership with our client Pfizer, is seeking a QC Analyst Micro to join the team for an 11-month fixed-term contract, onsite at their state-of-the-art plant in Dublin, Grange Castle. This is an onsite role.

Job Responsibilities:
  1. Perform microbiological testing analysis on, but not limited to, finished drug products, in-process materials, stability samples, and environmental monitoring.
  2. Responsible for calibration and use of laboratory instrumentation.
  3. Complete documentation associated with analytical results in a timely manner.
  4. Report and document any non-conformances to the QC Manager.
  5. Assist in the preparation and review of area documentation e.g. SOPs, Reports, Protocols.
  6. Assist in the training of other analysts.
  7. Ensure training compliance within assigned work area and QC.
  8. Perform and assist in additional duties as directed by the QC Manager.
  9. Ensure relevant assays are performed on samples in support of release test and stability test programs.
  10. Support any validation and qualification of test methods and processes.
  11. Facilitate laboratory investigations and support associated product investigations.
  12. Support laboratory inspection and audits.
  13. Troubleshoot laboratory methods and instrument problems.
  14. Establish and monitor trend analysis program.
  15. Contribute to the operations of the Quality Control Laboratories.
  16. Liaise with all customers, both internal and external.
  17. Record and review laboratory testing documentation to cGMP standard.
  18. Implement and adhere to appropriate levels of cGMP within the laboratory.
  19. Promote safety awareness and the established culture of IIF within the assigned work area.
  20. Ensure that sample analysis is conducted to meet batch disposition requirements.
Minimum Requirements:
  • Third level qualification in Science, Engineering, or equivalent is preferred though not essential. Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel).
  • Excellent communication and interpersonal skills.

This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties, or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.

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