Job Title: QC Analyst in Chemistry
Cpl in partnership with our Client Pfizer are seeking a highly skilled QC Analyst 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 where you will be part of Pfizer's dedicated and highly effective quality control team.
Your Key Responsibilities:
1. Develop and maintain quality programs, processes, and procedures that ensure compliance with established standards and agency guidelines.
2. Contribute to quality risk management by tracking commitments, interpreting policies, managing site complaints, and working directly with operating entities to provide process analysis oversight.
3. Ensure the quality assurance programs and policies are maintained and modified regularly, promoting uniform standards worldwide and best practice sharing.
You will be recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials, and equipment. You will adapt standard methods and procedures by applying your knowledge, prior work experience, and requirements.
Key Activities:
1. Perform analysis of quality control samples including raw materials, in-process, intermediates, stability, and finished products in line with Current Good Manufacturing Practices (GxP).
2. 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.
3. Adhere to good laboratory practices and housekeeping standards.
4. Assist in the generation and maintenance of Quality procedures and reports.
5. Facilitate laboratory investigations and support associated product investigation.
6. Analyse both wet chemistry and the use of analytical equipment including UV, HPLC, FTIR, KF, iCE, ICP, CE, and compendial assays.
Qualifications:
* Third-level qualification in Science, Engineering, or equivalent is 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 is preferred though not essential.
* Knowledge of computer applications, including MS Office, Excel, Laboratory Information Management System Access, and TrackWise.