QC Chemistry Analyst (Shift)

QC Chemistry Analyst (Shift)
RK20683
11 Months
Carlow



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties:

• 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,

• 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