Collins McNicholas

Role Description:

  1.  Physical-chemical control of raw materials and packaging materials.
  2.  Physical-chemical control of bulk and finished product.
  3.  Physical-chemical control of utilities e.g. water, air, environmental samples.

Role Responsibilities:

Analysis of materials:

  1.  Execute analysis of raw materials, in-process material, and finished product in compliance with schedule.
  2.  Complete analysis in accordance with SOP and standard methods.
  3.  Calculation of results and reporting of data, including trend analysis as required.
  4.  Execute analysis of water, cleaning samples etc as required.

Carry out routine maintenance activities for QC systems:

  1.  Execute calibrations and PM of equipment as required to ensure equipment is appropriate for use for analysis.
  2.  Co-ordinate maintenance schedules with external suppliers to ensure compliance with schedule and in-house procedures.
  3.  Preparation of all solutions, reagents etc. associated with analysis.
  4.  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.
  5.  Participate in the preparation of QC documents including SOPs, specifications, methods.
  6.  Participate in training and development activities to ensure that new technologies are applied, and that skill level is developed.
  7.  Execute validation studies and transfer studies to ensure equipment, methods and personnel are appropriately qualified.
  8.  Participation in QC and site projects by representing QC so as to provide an appropriate service to other departments.

Meet the quality and safety standards:

  1.  Ensure QC activities are executed in line in in-house procedures and in compliance with requirements of cGMP.
  2.  Ensure QC activities are executed in line with safety requirements and good laboratory practice.
  3.  Keep work area clean and tidy.
  4.  Keep up to date on regulatory development and standards by accessing in house library, accessing current Pharmacopoeias etc.
  5.  Participation in investigations into failures, out of trends and out of specifications as required.

Reporting and communication:

  1.  By reporting and communication to QC supervisor and or manager in timely fashion any events or incidents.
  2.  By participation in preparation of QC reports.
  3.  By completing checking of data to ensure accuracy and compliance.

Role Requirements:

  1.  Degree in an analytical science is preferred.
  2.  Previous experience in a laboratory environment and direct experience of HPLC analysis would be an advantage.
  3.  Analytical approach to tasks.
  4.  Good organisation skills.
  5.  Technical skills in analysis are important.
  6.  Proficient in Microsoft Excel and Word.
  7.  Fluent in English.
  8.  Behavioural skills: Judgement, initiative, concern for excellence, technical skills and competence, teamwork.

For a confidential discussion and more information on the role, please contact Aisling Lane on 021 4320675 or email

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