Senior QC Analyst
Senior QC Analyst- Galway
Our client a generic pharmaceutical manufacturer are seeking a Senior QC Analyst to join their team. This is an opportunity to be part of a dynamic team within the Quality Control function. In this role, you will carry out analytical testing on finished products and raw materials using the correct procedures in order to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring the company meets customer’s needs. You will also be asked to provide technical support as required by management.
- Displays the capability to learn and understand methods showing competency in the following technical areas: HPLC, IR, UV, dissolution & physical testing.
- 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.
- 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 injectable.
- 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.
- To maintain good housekeeping and hygiene within the laboratory.
- 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.
- Ensure records pertaining to QC are all kept up to date and filed properly.
Education and Experience:
- 3rd level qualification – Bachelor’s degree in a chemistry-based discipline.
- 4 + years’ experience in a Snr QC Analyst/ QC Analyst role.
- People management experience.
- Strong computer skills in MS Office.
- Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines.