- Reference: CJ43318yyyyyy
- Job Type: Permanent
- Location: Cork, Cork City, Munster
- Category: Production
This position will be responsible for but not including the following: ]
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.
- Participate in QC and site projects by representing QC so as to provide an appropriate service to other departments
Meet the Quality & 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 Analytical Science or Equivalent
- 2-3 years’ experience in GMP lab environment (preferably solid dose pharma)
- Direct experience of HPLC analysis an advantage, but strong raw materials testing experience would be considered
Experience of protein handling and ELISA analysis will be an advantage
For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email firstname.lastname@example.org
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