QC Leader

  • Cork
  • Permanent
  • JO-1710-62971_1509438211

Summary

Management of Laboratory Activities

  • Reports to the QA & Compliance Supervisor
  • Lead the QC team and coordinate their daily activities
  • Organise staff according to skills to plan workloads, rotas and ongoing QC resources
  • Hosting of laboratory tours during customer audits or Regulatory Inspections
  • Able to operate with accuracy and attention to detail.
  • Ensuring information is communicated and fed back effectively to the relevant
  • Training employees on laboratory methods, laboratory SOPs and correct laboratory techniques
  • Interpret data and use as a basis for routine decision making and actions.


Daily Activities:

  • Responsible for the release of QC testing on API Lercanidipine Hydrochloride
  • Responsible for updating disposition status on SAP of API batches and issuing Certificates of Analysis
  • Perform reviews and approvals on incoming raw materials and packaging
  • Manage, review and approve laboratory investigations and deviations
  • Participate in root cause analysis and risk assessments (where appropriate)
  • Monitor and trend laboratory data
  • Review, update and approve laboratory SOPs
  • Review, update and approve specifications and analytical methods
  • Responsible for the API Stability program
  • Oversee Cleaning validation and verification studies
  • Ensure maintenance and calibrations on laboratory equipment are performed
  • Troubleshooting on Laboratory equipment
  • Responsible for the introduction of new equipment in the laboratory
  • Responsible for backup and restore procedures in the laboratory
  • Responsible for Change controls and CAPAs generated in the QC department
  • Ensure all instruments meet data integrity standards
  • Hosting of laboratory tours during customer audits or Regulatory Inspections
  • Support Customer audits and Regulatory Inspections




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