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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.
- 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.
- 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 email@example.com