A QC Analyst is required for a biopharmaceutical in Carlow. This role offers a fantastic QC Analyst opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The QC Analyst will complete analytical method transfers and validation as well as routine testing. This a 2 cycle shift role with morning and evening shifts.
- Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP.
- Required to drive compliance with the company’s 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/UPLC, (HIC,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 site.
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.
- Method validation and method transfer experience would be Advantage.
- Occasional travel may be required for training purposes.
To apply for this job email your details to email@example.com.