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Analytical Quality Specialist
1 week ago
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.