Our client is currently going through an unprecedented and exciting period of growth and development and is now looking for committed and motivated Chemistry Analysts to join their team. This is a permanent position and training will take place in Galway.
Job Title: Chemistry Analyst
- Set up, maintain, and review the Laboratory Quality system to ensure compliance with GMP as defined in European Directives and CFR Parts 210 and 211.
- Selection, installation, qualification, and ongoing maintenance of laboratory equipment in accordance with the company XXX laboratory Quality system and GMP.
- Generation of documentation to support test method transfers from clients
- Execution of testing as per approved protocols and test method etc
- Write up all test results as per GMP and in accordance with the Quality System including Out of Specification results and Laboratory Deviations
- Review and approval of Laboratory quality records as per GMP and in accordance with the Quality System E.g. Out of specification results, laboratory deviations, etc.
- Training of junior staff
- Participation in self-inspections audits
- Communicate with customers in relation to technical queries, forecasting, etc
- GMP review of Laboratory log books
- Participate in Laboratory audits e.g. Regulatory /Customer
- Execution of analytical testing as per approved protocols, current Pharmacopoeia and test methods, etc.
- Write up and reporting of all test results as per cGMP, GLP, and in accordance with the Quality System including Out of Specification results and Laboratory Deviations.
- Participation in self-inspection audits.
- Participate in Laboratory external audits e.g. Regulatory (HPRA) and customer audits.
- Calibration and maintenance of Laboratory equipment including Balances, pH meter, Conductivity meter, Karl Fischer, glassware drying oven temperature, and auto pipettes.
- HPLC analysis using Empower 3 of raw materials, excipients, and finished products.
- Validation/Qualification studies and projects.
- Must have a Degree in Chemistry, Forensic investigation & analysis or a similar degree with strong laboratory analysis focus.
- The Candidate should have experience with HPLC/UPLC using Empower, GC, etc. from a GMP environment.
- ICP-MS experience would be a strong advantage.
- Must be open on location.
For more information or a confidential discussion about this role please contact Michelle McInerney
091 706 717