Collins McNicholas

QC Analyst X 2

Duties and Responsibilities: 

  • Execute analysis of raw materials, in-process material, and finished product in compliance with schedule.
  • Complete analysis in accordance with SOP and standard methods.
  • Calculation of results and reporting of data, including trend analysis as required.
  • Execute analysis of water, cleaning samples etc as required.
  • Execute calibrations and PM of equipment as required to ensure equipment is appropriate for use for analysis.
  • Co-ordinate maintenance schedules with external suppliers to ensure compliance with schedule and in house procedures.
  • Preparation of all solutions, reagents etc. associated with analysis.
  • Execute stock control on laboratory consumables including reagents, solvents to ensure there is adequate supply to execute tasks. Complete purchase orders as required and manage materials on receipt.
  • Participate in the preparation of QC documents including SOPs, specifications, methods.
  • Participate in training and development activities to ensure that new technologies are applied and that skill level is developed.
  • Execute validation studies and transfer studies to ensure equipment, methods and personnel are appropriately qualified.
  • Participation in QC and site projects by representing QC so as to provide an appropriate service to other departments.
  • Ensure QC activities are executed in line in in-house procedures and in compliance with requirements of cGMP.
  • Ensure QC activities are executed in line with safety requirements and good laboratory practice.
  • Keep work area clean and tidy.
  • Keep up to date on regulatory development and standards by accessing in house library, accessing current Pharmacopoeias etc.
  • Participation in investigations into failures, out of trends and out of specifications as required.

Candidate Requirements

Degree with relevant experience in a Pharmaceutical laboratory environment 

 

For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email rory.walsh@collinsmcnicholas.ie

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