Job ID: JOB-11782
Our client, a leading pharmaceutical company in Galway is looking to attract a QC Analyst to join their team. This is a permanent position, and in this role you will be carrying out analytical testing on finished product & raw materials using the approved procedures in order to comply with cGMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring to meet customer’s needs.
- Maintain and follow all relevant Standard Operating Procedures (SOP’s).
- Adherence to the existing methods with reference to pharmacopoeia’s, specifications, regulations and industry standards.
- Adherence to regulatory and industry compliance and data integrity expectations.
- Displays technical competency and full understanding of methods and equipment relating to the following areas: HPLC, UPLC, GC, IR, UV, ICP, particle size, dissolution & physical testing.
- Full analysis of raw materials in a timely manner using appropriate analytical techniques with limited analyst related OOS.
- Full analysis of finished product (tablets, boluses, veterinary drenches etc) in a timely manner using appropriate analytical techniques with limited analyst related OOS.
- Full analysis of contract manufactured products in accordance with customer specifications with limited analyst related OOS.
- Incoming inspection of foils, labels, bulk finished goods and injectables.
- Calibration and maintenance of laboratory equipment as per calibration procedures.
- To support the laboratory testing schedule in order to achieve an efficient QC system and Customer Service level of >95%.
- To maintain all laboratory logbooks, notebooks & associated documentation to GLP.
- Liaise with team leader/supervisor & production so that timely reporting of results is achieved.
- Ensure timely feedback of all queries as appropriate.
- To bring to the notice of the team leader/supervisor any discrepancies, deviations or non-conformances in testing or work practice.
- Display ability and follow up on Corrective Actions.
- Sending out samples for external analysis when requested.
- Participating in internal/External Audits.
- Liaising with external suppliers/vendors in relation to QC consumables.
- Ensure existing quality procedures are followed and where appropriate suggestions/change control forms are prepared so that the quality system will be continuously improved.
- To adhere to any agreed internal laboratory rota tasks.
- Adherence to laboratory safety measures at all times highlighting areas for improvement.
- Ensuring that laboratory is kept tidy and that GLP/GMP standards are adhered to at all times
- Bachelor’s degree in a science-based discipline with a minimum of 6 years’ experience in pharmaceuticals.
- Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines
- Technical skills along with strong computer skills in MS Office and knowledge of enterprise systems i.e. SAP.
- A methodical, systematic and structured approach to organising work
- Ability to prioritise decision making differentiating between urgent and non-urgent
- Escalates issues appropriately
- Any other duties as assigned by the QC team leader/supervisor or manager
For further information on this role in please contact Mark Wilson on 0860449473 or email firstname.lastname@example.org
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