QC Biosimilars Analyst

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 analysis on raw material, In-process tests, intermediates and API (Active Pharmaceutical Ingredients) in line with Current Good Manufacturing
  Practices (GMP).
• 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.
• 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
• 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
• Knowledge of Capillary Gel Electrophoresis (CGE) and Imaged Capillary Electrophoresis (iCE).
• 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.

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 

​ 

How to apply 

• Make a difference today, all suitable candidates should apply with CV below.  We are looking forward to hearing from you! 

​

Purpose  

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. 

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. 

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. 

Manufacturing