Job Description

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. Pfizer Grange Castle, one of the largest integrated bio pharmaceutical plants in the world is a multi product site and integral to the Pfizer network. The Grange Castle facility will also be expanding to include a second Drug Substance Facility which will bring further innovative and critical medicines and treatments to our patients

If you have relevant QC (Quality Control) Chemistry experience, this is a fantastic opportunity to join us on our journey to manufacture and test product breakthroughs that change patients' lives!

The QC DS Proteins team are expanding and analysts joining our team will maintain regulatory compliance through established programs for laboratory testing, maintenance, training, and SOPs within the laboratory. Our team is responsible for testing the largest variety of products manufactured here in the Drug Substance facility and External Pfizer Sites, and we celebrate our successes via recognitions!

 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 train others and reinforce behaviours that will help us achieve our goal of providing the best to patients.

Together we will ensure that Science will win.

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 analysis on drug substance, drug product, In-process tests and intermediates in line with Current Good Manufacturing Practices (GMP).
• Write up and execute Analytical Method Transfer Exercises for products being transferred to site 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.
• Participate, and seek opportunities, in the areas of Right First Time, Continuous Improvement and unburdening activities to facilitate Lean/Agile implementation.
• Contribute to completion of project milestones and organize own work to meet project task deadlines.
• Respond to safety related items and assures corrective actions are taken when necessary.
• Responsible for identifying and implementing efficiency, safety, quality and cost improvements on equipment and processes.
• Assures standard operating procedures are updated and adhered.

Qualifications

Must-Have

• Third level Qualification in Science, Engineering or equivalent is preferred though not essential.
• Minimum 2 - 4 years’ experience working in 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
• Experience in reviewing and approving documented analytical testing, SOPs and related GMP documents
• 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, Empower 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.