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Collins McNicholas

This is an opportunity to join a dynamic, progressive and growing multinational organization in the life science industry. This role will support all aspects of the analytical process and method transfer utilizing both HPLC and GC methods.

Role Responsibilities:

Product Support:

  • Implement laboratory work for allocated priority assigned studies.
  • Provide analytical support to the scale up and registration of new products (NPI).
  • Develop and validate robust analytical methods suitable for the evaluation of novel formulations.
  • Generate test data to characterise trial formulations and to facilitate product support and scale-up studies.
  • Participate in the technical transfer of analytical methods within the company and to other facilities.
  • Write and/or review procedures, protocols, study plans and reports.
  • Conduct all laboratory tasks in a responsible quality focussed way and with due regard to all health, safety and environmental regulations 

Analysis of Materials:

  • Undertake raw material, intermediate, finished product testing and cleaning verification associated with Site Technology projects and stability monitoring programmes product in compliance with schedule when required.
  • Complete analysis in accordance with SOP and standard methods
  • Calculation of results and reporting of data, including trend analysis as required
  • Record all test details, raw data and results accurately, neatly and in a timely manner, in line procedures and GMP principles

Carry out routine maintenance activities for analytical 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 documents including SOPs, specifications, methods.
  • Participation in investigations into failures, out of trends and out of specifications as required.

 

 Role Requirements: 

  • BS in a scientific discipline or related experience
  • Minimum of 2 years’ experience in a Quality related field
  • Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, Access, PowerPoint)
  • Good oral, written, and presentation skills
  • Sound decision making and problems solving skills to assure business unit compliance
  • Strong analytical skills, ability to analyse data and trends and draw conclusions
  • Good mathematics background with an understanding of basic statistical concepts

 

For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email aisling.lane@collinsmcnicholas.ie

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