QC Analyst

3 weeks ago

Dublin, Dublin City, Ireland CPL Healthcare Full time

Cpl in partnership with Pfizer is looking for experienced Quality Control Analyst to join their DS Vaccines team

at Grange Castle site.

The main task is to p erform in-process and final product testing on Vaccines Drug Substance using different methods and analytical techniques, including wet chemistry, HPLC and UV Vis.

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 assurance and 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.

·Perform In-process and final product testing on Vaccines Drug Substance in line with Current Good Manufacturing Practices (GMP).

·Ensure sample analysis is conducted to meet batch disposition 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.

·Participate, and seek opportunities, in the areas of Right First Time, Continuous Improvement and unburdening activities to facilitate Lean/Agile implementation.

·This position is days with the possibility of extended shift based on business needs

Qualifications

Must-Have

·Third level Qualification in Science, Engineering or equivalent is preferred though not essential.

·Minimum 2+ years experience working in QC Laboratory

·Demonstrate proven experience with analytical techniques including UV Testing and Good Manufacturing Practices (GMP)

·Strong knowledge of analytical techniques both theoretical and practical

·Detail oriented, quick at decision making, and self-motivated with good trouble shooting

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, Empower and TrackWise

·Demonstrate proven experience with analytical techniques including HPLC Testing

Additional Information

·In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.

·Please note there is no relocation support available for this position.

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