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Analytical Quality Specialist

1 week ago


Dublin, Dublin City, Ireland Cpl Healthcare Full time

Company Overview

Cpl Healthcare, in partnership with Pfizer, is seeking a highly skilled QC Analyst to join their Chemistry division team at the state-of-the-art site in Dublin, Grange Castle.

This on-site role offers an exciting opportunity for individuals who want to contribute to ensuring quality standards and compliance with established regulations.

Key Responsibilities:

  • Develop and maintain quality programs, processes, and procedures to ensure compliance with regulatory guidelines.
  • Analyze quality control samples, including raw materials, in-process, intermediates, stability, and finished product, in line with Current Good Manufacturing Practices (CGMP).
  • Execute Analytical Method Transfer Exercises for products being transferred to the Grange Castle site, ensuring compliance with site, Pfizer Quality Standards (PQS), International Conference on Harmonization guidance, and Filing requirements.
  • Adhere to good laboratory practices and housekeeping standards.
  • Assist in generating and maintaining Quality procedures and reports.
  • Facilitate laboratory investigations and support associated product investigation.
  • Analyze wet chemistry and utilize analytical equipment, including UV, HPLC, FTIR, KF, iCE, ICP, CE, and compendial assays.
  • Participate in Right First Time, Continuous Improvement, and unburdening activities to facilitate Lean/Agile implementation.

Requirements:

  • A Third-level qualification in Science or Engineering is preferred, though not essential.
  • Strong knowledge of analytical techniques, both theoretical and practical.
  • Excellent interpersonal and communication skills.
  • Detail-oriented, quick decision-making, self-motivated, with good troubleshooting and problem-solving abilities.