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Job Description
QC Chemistry Analyst role in a Pharmaceutical organization in Carlow, requiring a Bachelor's Degree in Analytical Chemistry or related field, with 2-3 years of experience in a pharmaceutical laboratory.
We're seeking a highly skilled QC Chemistry Analyst to join our team in Carlow. As a key member of our Quality Control team, you will be responsible for ensuring the quality and integrity of our products.
Key Responsibilities:
- Work as directed by the Quality Control Manager to ensure compliance with Company safety policies, cGMP, and cGLP.
- Drive compliance with Global policies, procedures, and guidelines, and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities.
- Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations, etc.
- Operate as part of the QC team performing allocated testing and laboratory-based duties.
- Perform various analytical techniques, including HPLC, Capillary Electrophoresis, and other compendial test methods in compliance with GMP requirements.
- Peer review testing documentation and ensure 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.
- Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods.
Requirements:
- Bachelor's Degree or higher in Analytical Chemistry or a closely related discipline.
- 2-3 years of experience in a pharmaceutical laboratory.
- Good working knowledge of HPLC systems and software.
- Good knowledge of cGMP, GLP, and Quality Management Systems.