Cpl in partnership with our Client Pfizer are seeking QC Analyst in Chemistry to join the team on site at their state of the art site in Dublin, Grange Castle for a contingent fixed term contract.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective quality control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitment tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of company's mission globally.
You will be recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will arrive at decisions on which methods and procedures are the best fit for different work situations. You will train others and reinforce behaviours that will help us achieve our goal of providing the best to patients.
How You Will Achieve It
· Perform analysis on raw material, In-process tests, intermediates 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 from the legacy facility, 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.
· Analyse both wet chemistry and the use of analytical equipment including, UV, HPLC and CE.
· Participate, and seek opportunities, in the areas of Right First Time, Continuous Improvement and unburdening activities to facilitate Lean/Agile implementation.
Qualifications
Must-Have
· Third level Qualification in Science, Engineering or equivalent is preferred though not essential.
· Some experience working in a QC Laboratory.
· Demonstrate proven experience with analytical techniques including high-performance liquid chromatography (HPLC) and Good Manufacturing Practices (GMP)
· 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
· Experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment
· Knowledge of computer applications, including MS Office, Excel, Laboratory Information Management System Access and Track wise
· This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.