- 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.
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.
- Degree in an analytical science is preferred.
- Previous experience in a laboratory environment and direct experience of HPLC analysis would be an advantage.
- Analytical approach to tasks.
- Good organisation skills.
- Technical skills in analysis are important.
- Proficient in 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 email@example.com