Job Description
Cpl, in partnership with our Client Pfizer, are seeking a QC Analyst in the Chemistry division to join their team at the state-of-the-art site in Dublin, Grange Castle.
This is an on-site role that offers the opportunity to be a member of Pfizer's dedicated and highly effective quality control team.
Responsibilities
* Develop and maintain quality programs, processes, and procedures to ensure compliance with established standards and agency guidelines.
* Contribute to quality risk management, interpreting policies, manage site complaints, and work directly with operating entities to provide process analyses oversight.
* Ensure quality assurance programs and policies are maintained and modified regularly, promoting uniform standards worldwide and best practice sharing.
Key Activities
1. Perform analysis of quality control samples, including raw materials, in-process, intermediates, stability, and finished product 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 generating and maintaining quality procedures and reports.
5. Facilitate laboratory investigations and support associated product investigation.
6. Analyze both wet chemistry and the use of analytical equipment, including UV, HPLC, FTIR, KF, iCE, ICP, CE, and compendial assays.
Requirements
* Third-level qualification in Science, Engineering, or equivalent preferred.
* Strong knowledge of analytical techniques, both theoretical and practical.
* Excellent interpersonal and communication skills.
* Detail-oriented, quick at decision-making, self-motivated, with good trouble-shooting and problem-solving abilities.
Nice-to-Have Qualifications
* Experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment.
* Some experience working in a QC Laboratory or production environment.
* Knowledge of computer applications, including MS Office, Excel, Laboratory Information Management System, Access, and Trackwise.