Job Description
Cpl in partnership with our Client Pfizer are seeking a highly skilled Quality Control Analyst to join their team at the state-of-the-art site in Dublin, Grange Castle for a contingent fixed-term contract. This is an on-site role.
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 providing process analyses oversight.
* Ensure preparedness for all upcoming audits and inspections.
Key Performance Indicators (KPIs):
1. 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).
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 but not limited to UV, HPLC, FTIR, KF, iCE, ICP, CE, and compendial assays.
7. Participate in 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 Qualifications:
* 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.
What We Offer:
Candidates who complete the recruitment process and are selected as successful will be offered roles in specific teams within the Chemistry space as QC Analyst depending on their skills, experience, and current vacancy requirements.