QC Analyst

  • Cork
  • Contract 12 months
  • JO-1712-63048_1512390735

Summary

QC Analyst
12-month contract
Job Purpose:
Testing of pharmaceutical drug substances and drug products in accordance with corporate procedures and in compliance with the current GMP standards.
Responsibilities:

  • Carry out testing of drug substances and drug products in accordance to the valid testing procedures and regulatory
  • Ensure that laboratory equipment is well maintained and calibrations are carried out at the designated frequencies.
  • Review results generated by other analysts for compliance with requirements.
  • Ensure correct data entry to LIMS.
  • Ensure that all target dates are met.
  • Maintain laboratories to a high housekeeping standard.
  • Carry out method transfers and participate in the validation of analytical test methods as required.
  • Write and maintain necessary documentation (test protocols, SOPs, instrumentation manuals and checkout sheets, method transfer reports, OOS reports, etc.) according to the existing SOPs and cGMP standards.
  • Assessment of testing results generated in the laboratory and close out of batch analysis.
  • Maintain a safe working environment.
  • Deputize for QC Coordinator as required.


Requirements:

  • BSc. Chemistry or similar
  • 1 years' experience in QC within the pharmaceutical industry.
  • Familiarity with current Good Manufacturing Practices and sound knowledge of analytical technologies
  • Experience in analytical testing (HPLC, GC, UV, wet chemistry, dissolution, etc.), good organisational skills, computer experience

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