QA Specialist

Job description

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes. What You Will Achieve In this role, you will: Review and approve master batch records and completed batch records for the manufacture, packaging, and labelling of intermediates and active pharmaceutical ingredients (APIs), ensuring compliance with Pfizer quality standards and registered regulatory specifications. Perform disposition of intermediates and active pharmaceutical ingredients (APIs). Review and approve cleaning instructions and records, ensuring compliance with Pfizer Global and Local Document Standards and ICH guidelines. Review and approve GMP documents, including SOPs, protocols, reports, and change controls, for compliance with Pfizer Global and Local Document Standards. Ensure compliance with quality procedures, regulatory requirements, and current Good Manufacturing Practices (cGMP). Review and approve deviations in accordance with site procedures, including investigation reports, root cause analyses, corrective and preventive actions, and quality, validation, stability, and regulatory impact assessments conducted with subject matter experts. Maintain quality tracking systems and metrics to proactively identify trends and atypical observations. Support preparation of Annual Product Records, evaluate trends and atypical observations, and recommend improvement actions. Maintain inspection readiness and support regulatory and customer inspections. Participate actively in GMP walkdowns to keep site operations and facilities inspection-ready. Support maintenance of the validated state of GMP systems and processes. Support regulatory submissions and respond to regulatory queries promptly. Uphold Pfizer's code of conduct and values, demonstrate Pfizer actionable attributes. Contribute actively within the assigned Value Stream Team (VST) by reporting performance against metrics, identifying and resolving issues, and escalating concerns appropriately. Support continuous improvement of Quality Assurance systems, as needed. Participate actively in safety initiatives and conduct Environment, Health and Safety (EHS) investigations as required. Here Is What You Need (Minimum Requirements) Diploma with at least 4 years of relevant experience or BA/BS with at least 1 year of relevant experience Experience in the pharmaceutical industry and Quality administered systems Sound knowledge of current Good Manufacturing Practices (part of GxP) Ability to work effectively in a team environment, both within one's own team and interdepartmental teams Effective written and oral communication skills Bonus Points If You Have (Preferred Requirements) Experience at a manufacturing site. Managing and writing deviations Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management Strong problem-solving skills Ability to work independently and as part of a team Excellent time management and multitasking abilities Experience using common AI tools, including generative technologies such as Microsoft Copilot to support problem solving and enhance Work Location Assignment: On Premise Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers . Quality Assurance and Control