QC Chemistry Analyst

2 weeks ago


Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full time

Summary:
Our client, a biopharmaceutical company based in Carlow, is hiring a QC Chemistry Analyst. The perfect candidate will handle analytical method transfers, validation, and commercial testing to facilitate the release of crucial drug products.

Responsibilities:

  • Follow instructions from the Quality Control Manager in line with company safety policies, cGMP, and cGLP.
  • Ensure compliance with Global policies, procedures, regulatory requirements, and execute Good Manufacturing Practices (cGMP) daily.
  • Participate in daily QC Tier 1 meetings, communicate testing progress effectively, and address deviations.
  • Assist in developing accurate operational procedures, training materials, and maintenance procedures for various Quality systems.
  • Collaborate with the QC team to conduct assigned testing and laboratory-based tasks.
  • Conduct various analytical techniques such as HPLC, Capillary Electrophoresis, etc., in accordance with GMP requirements.
  • Review testing documentation, ensure data integrity compliance, and achieve QC Right First Time KPIs.
  • Contribute to OOS investigations in the laboratory.
  • Provide assistance with audit and inspection requirements to ensure department compliance.
  • Participate in internal and external audits and inspections, acting as auditee for specific areas.
  • Promote continuous improvement, conduct root cause analysis on system failures, resolve equipment performance issues collaboratively, and drive a safe culture in Carlow.

Qualifications & Experience:

  • Preferably a Bachelor's Degree or higher in Analytical Chemistry/Biochemistry or related field.
  • 2-3 years of experience in a pharmaceutical laboratory.
  • Familiarity with HPLC systems and software is advantageous.
  • Solid understanding of cGMP, GLP, Quality Management Systems.
  • Occasional travel may be necessary for training.

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