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QC Compliance Officer

QC Compliance Officer- Galway- 12 month FTC

Our client are looking for a QC compliance officer to join their team. This role will monitor the  Quality Systems for the QC/QA department and will work on continuously improving areas
impacted by deviations.

Key Responsibilities:

  • Write and revise standard operating procedures (SOPs).
  • Prepare finished product and Raw material test procedure.
  • Displays competency in the following technical areas: HPLC, IR, UV, dissolution & physical testing etc.
  • Adherence to the existing methods with reference to pharmacopoeia’s, specifications, regulations and industry standards.
  • Prepare analytical method transfer protocol and report.
  • Prepare and review of out of specification, Out of Trend, Change control.
  • Review calibration and maintenance of laboratory equipment as per calibration procedures.
  • To maintain all laboratory logbooks, notebooks & associated documentation to GLP standard.
  • Liaise with team leader/supervisor & production so that timely reporting of results is achieved.
  • Ensure timely feedback of all queries as appropriate.
  • To bring to the notice of the team Manager/supervisor any discrepancies, deviations or non conformances in testing or work practice.
  • Display ability and follow up on Corrective Actions.
  • Participating in internal/External Audits.
  • Ensure existing quality procedures are followed and where appropriate suggestions/change control forms are prepared so that the quality system will be continuously improved.
  • To maintain good housekeeping and hygiene within the laboratory.
  • Adherence to laboratory safety measures at all times highlighting areas for improvement
  • Ensuring that laboratory is kept tidy and that GLP/GMP standards are adhered to at all times
  • Ensure records pertaining to QC are all kept up to date and filed properly.
  • Proficiency with Microsoft applications, including Word and Excel and environmental systems.
  • Any other duties as assigned by the QC team leader/supervisor or manager

Education and Experience:

  • 3rd level qualification – Bachelor’s degree in a science-based discipline.
  • Strong computer skills in MS Office
  • Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines
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Job Details

Galway
16 October 2023
Job ID: 8764

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