Our client, a biopharmaceutical company located in Carlow, is looking for a QC Chemistry Analyst. The ideal candidate will complete analytical method transfers and validation as well as commercial testing to support the release of key drug products.
- Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP.
- Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
- Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same.
- Operate as part of the QC team performing the allocated testing and laboratory-based duties.
- Perform various analytical techniques including but not limited to HPLC, (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements.
- Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
- Participate in the laboratory aspects of OOS investigations.
- Provide support with audit/inspection requirements to ensure department compliance/readiness.
- Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
- Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why’s etc.
- Work collaboratively to drive a safe and compliant culture in Carlow.
Qualifications & Experience:
- Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline.
- 2-3 years of experience in a pharmaceutical laboratory.
- A good working knowledge of HPLC systems and software is desirable.
- A good knowledge of cGMP, GLP, Quality Management Systems.
- Occasional travel may be required for training purposes.
To apply for this job email your details to firstname.lastname@example.org.