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.
- 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