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QC Supervisor (Evening Shift)

QC Laboratory Supervisor (Evening Shift)

Our client a generic pharmaceutical manufacturer are looking for a QC laboratory Supervisor to join their dynamic team within the Quality Control function.  In this role you will required to provide technical expertise to assist in the analytical testing on finished product & raw materials using the correct procedures in order to comply with cGMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customer’s needs. You will also be required to provide support as required to the QC Laboratory Manager.

Key Responsibilities:

  • Ensure that all testing is conducted in accordance with current EU and Pharmacopeial requirements. Data integrity is of paramount importance and must comply with current guidelines.
  • Ensure proper supporting to analysts to guarantee to meet Key Performance Indicators (KPI’s) to Laboratory function.
  • Ensure completion of testing to allow for timely release of raw materials for use in manufacture and finished product for release to the market.
  • Ensure timely review and approval of laboratory results, protocols and reports for finished product and stability.
  • Provide technical guidance in the event of equipment failure, calibration failure, out of specification results and any other issues as appropriate. Ensure all laboratory equipment is maintained and calibrated.
  • Perform detailed root cause investigations into out of specification results or any analytical errors that occur in the laboratory.
  • Ensure timely completion and support analyst for method transfer activities in accordance with relevant procedures.
  • Ensure adherence to all relevant Standard Operating Procedures (SOP’s), Calibration and Operation Instructions (COI’s) and existing test methods with reference to pharmacopoeia’s, specifications, regulations, and industry standards.
  • Support to Scheduling of analysis, prioritising work 
  • Maintain statistical trend analysis is completed in accordance with current GMP/GLP requirements.
  • Support Reviewers to Review all laboratory notebooks, records, chromatograms etc. to an acceptable GLP standard and up to date at all times.
  • Guarantee that all consumables are always available.
  • Guarantee that relevant Working standard and Reference standard are always available and not expired.
  • Assist the QC Manager in hosting Regulatory inspections and Customer audits.
  • Ensure that corrective actions identified because of observations raised during regulatory & customer audits are implemented in a timely manner.
  • Ensure that all GMP related documentation is regularly reviewed and updated in accordance with Company policy.
  • Support QC Manager in Review and approval company standard operating procedures.
  • Support QC Manager to maintain monthly measurements on Key Performance Indicators (KPI’s) to reflect the performance of the Laboratory function.
  • Conduct performance reviews with Laboratory personnel in accordance with the Company performance management system.
  • Identify training and on-going development opportunities for laboratory personnel and training records maintained.
  • Ensure that continuous improvement initiatives are identified and implemented in the laboratory as appropriate.
  • Assist in the selection and recruitment of Laboratory personnel in conjunction with Human Resources and QC Manager
  • Monitor the laboratory capacity to ensure that the resources meet the requirements of the business and take appropriate corrective measures as required.
  • Ensure the laboratory operates within the requirements of the budget on a monthly basis.
  • Any other duties assigned by the QC Manager
     

Education and Experience:

  • 3rd level qualification – bachelor’s degree in a science-based discipline.
  • Minimum of 5 years in a pharmaceutical’s environment.
  • Strong computer skills in MS Office
  • Experience working within a pharmaceutical cGMP Environment; with knowledge of EU GMP

 

 

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Job Details

Galway
13 October 2023
Job ID: 8757

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