Job Description:
Cpl, in partnership with our Client Pfizer, are seeking a QC Analyst in the Chemistry divisions to join the team at their state-of-the-art site in Dublin, Grange Castle for a contingent fixed-term contract. This is an on-site role.
Key Responsibilities:
* Develop and maintain quality programs, processes, and procedures to ensure compliance with established standards and agency guidelines.
* Contribute to quality risk management by tracking commitments, interpreting policies, managing site complaints, and working directly with operating entities to provide process analyses oversight.
* Ensure that quality assurance programs and policies are maintained and modified regularly.
Accountabilities:
* Perform analysis of quality control samples, including raw materials, in-process, intermediates, stability, and finished product, in line with Current Good Manufacturing Practices (part of GxP).
* Write up and 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 the generation and maintenance of Quality procedures and reports.
* Facilitate laboratory investigations and support associated product investigation.
* Analyze both wet chemistry and the use of analytical equipment, including but not limited to UV, HPLC, FTIR, KF, iCE, ICP, CE, and compendial assays.
* Participate in the areas of Right First Time, Continuous Improvement, and unburdening activities to facilitate Lean/Agile implementation.
Requirements:
* Third-level qualification in Science, Engineering, or equivalent preferred though not essential.
* Strong knowledge of analytical techniques, both theoretical and practical.
* Excellent interpersonal and communication skills.
* Detail-oriented, quick at decision-making, self-motivated with good troubleshooting and problem-solving abilities.
Nice-to-Have:
* Experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment.
* Some experience working in a QC Laboratory or production environment preferred though not essential.
* Knowledge of computer applications, including MS Office, Excel, Laboratory Information Management System Access, and Trackwise.