QC Analyst

4 weeks ago

Dublin, Dublin City, Ireland Cpl Full time

Cpl in partnership with our client Pfizer are seeking QC Analyst- Immunology candidates to join the team for a contingent fixed term contract of 11 months at their state of the art plant in Dublin, Grange Castle.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

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 commitments 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

  • Manage own time, professional development and accountable for own results.
  • Prioritize own workflow, allocate work of others and assist in establishing their priorities.
  • Responsible for providing input for performance assessment on team members.
  • Perform analysis on raw material, In-process tests, intermediates and API (Active Pharmaceutical Ingredients) 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.
  • Analyse other materials, as required, including samples relating to investigations, development and stability.
  • 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 Biological Methods (ELISA, Blotting, Enzyme Assays) and the use of analytical equipment.
  • Participate, and seek opportunities, in the areas of Right First Time, Continuous Improvement and unburdening activities to facilitate Lean/Agile implementation.
  • Develop best practices and share with other teams and sites.

Qualifications

Must-Have

  • BSc in Life Sciences/Biological Sciences
  • 2+ years' experience preferred
  • Relevant experience in a technical role in a pharmaceutical/healthcare laboratory
  • Demonstrate proven experience with analytical techniques including ELISA, Blotting Techniques, Enzyme Activity Assays
  • Previous relevant experience within a QC Good Manufacturing Practices {also cGMP} laboratory in a Pharmaceutical/Biotechnology company
  • 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

  • Bachelor's Degree
  • 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 Trackwise

Work Location Assignment: On Premise

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