QC Chemistry Analyst

3 weeks ago


Dublin, Dublin City, Ireland Life Science Recruitment Full time

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,

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,
Education and 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
If interested in this posting please feel free to contact Rachel Kent on or for further information.

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