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

As a member of Pfizer's quality assurance team, you will play an important role in ensuring the safety and efficacy of our clinical and commercial batches of drug substance protein. The new Drug Substance Proteins 2 (DS2) manufacturing facility is currently under construction and will require collaboration with multiple experts within the site and the project team to deliver the best solution.

Your expertise will be utilized to thoroughly evaluate and review processes and electronic systems, ensuring data aligns with established specifications founded on precise sampling plans and effective procedures. This approach will enable you to identify any changes or deviations from established procedures in the manufacturing processes, electronic systems, QMS or various validation studies. In instances where deviations or changes are identified, you will be empowered to progress investigations and change control activities, safeguarding the integrity of the manufacturing process.

As a Senior Associate, your extensive knowledge and skills will significantly contribute to achieving the team's goals and objectives. A focus and consistent ability to meet team targets will play a pivotal role in completing deliverables on time to the right procedural standards. Strong communication skills, and process understanding will facilitate clear and effective explanations of complex issues, fostering collaboration and consensus among diverse teams.

How You Will Achieve It

• Assess a wide range of moderate to complex GMP & GxP activities and determine potential impacts.
• Pro-actively contribute to the Quality Management System and assure completeness in terms of procedural requirements and one best way.
• Develop a positive culture of Quality and Data Integrity by developing relationships with others.
• Accurately communicate diverse perspectives while remaining inclusive and equitable in everything we do.
• Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, regulatory requirements, and industry standards.
• Author, Review or approval of risk assessments, sample and test protocol rationale, and validation studies of facility, utilities, equipment, computerised systems, and manufacturing processes.
• Author, Review or Approve various QMS documents such as SOPs, APQRs, investigations, market query responses, commitments, audit observations, change controls, forms, logbooks, protocols, and reports.
• Review and approve master batch records, MES templates, LIMs sample plans, SAP genealogy, and executed batch records to assure compliance with regulatory standards and regulatory filing.
• Provide Quality oversight in the development and implementation of the Manufacturing Execution System (MES) in DS2; provide guidance and make decisions on Quality & Compliance issues related to MES; approve AMPS Documentation, Recipes and Master data; Review and close executed EBRs as part of the Batch disposition process, using Review by Exception (RBE).
• Complete batch disposition packs including review and troubleshooting of paper records and electronic quality management systems such as MES, LIMs, SAP.
• Implement continuous improvement activities and support all elements of the QMS such as Computerised systems, Validation Studies, Quality Risk Management, Operational Excellence, Change Controls, Events, Deviations, Laboratory Investigations, Projects, Periodic reviews, Customer Complaints, Stability, Raw Material Compliance, Supplier Quality Management, Metrics, Inspection Readiness, Internal Audits, Documentation Management, Quality Agreements, Pfizer Network initiatives, Training and regulatory documentation.

Must-Have

• Bachelor's Degree
• 3+ years' GMP experience
• Relevant Experience in both electronic and paper Quality Management Systems
• Confident in the use and navigation of a wide range of computerised systems and applications
• Knowledge of current Good Manufacturing Practices and the pragmatic application of GxP regulations and company standards
• Have a proactive agile approach combined with critical thinking skills.
• Make informed decisions, solve problem effectively and adapt to change
• Effectively manages stressful situations and well ableto focus on the task at-hand under various circumstances and timeline constraints.
• Thrives within a diverse and inclusive team environment.
• Excellent communication and interpersonal skills
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Willing to lead by example and jump right in
• Desire to get things done, collaborate and actively listen.