Collins McNicholas

 

Role Description:

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

 

Role Responsibilities:

 

Analysis of materials:

  • 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.

 

Carry out routine maintenance activities for QC systems:

  • 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.

 

Meet the quality and safety standards:

  • 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.

 

Reporting and communication:

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

 

Role Requirements:

  • Degree in an analytical science is preferred.
  • Previous experience in a laboratory environment and direct experience of HPLC analysis 
  • Analytical approach to tasks.
  • Good organisation skills.
  • Technical skills in analysis are important.
  • Proficient is Microsoft Excel and Word.
  • Fluent in English.
  • 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 aisling.lane@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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