Associate Manager - Quality Compliance
Pfizer INC · 🌍 India - Vizag
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About the role
Use Your Power for Purpose Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety. Qualifications: Education • Bachelor's or Master's Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, Biotechnology, Microbiology, or a related discipline. Experience: • 8–12 years of experience in Quality Assurance, Quality Compliance, Data Integrity, Market Complaints, or Quality Systems within the pharmaceutical industry. • Experience in regulated sterile manufacturing environments. • Exposure to global regulatory inspections (US FDA, MHRA, EMA, WHO, TGA, Health Canada, etc.). • Experience with eQMS, laboratory systems, and manufacturing systems is preferred. Data Integrity Management • Partner with the Site Data Integrity Lead to promote good data management practices and a strong Data Integrity culture across GxP functions. • Support implementation and maintenance of Data Integrity Governance programs in line with regulatory and corporate requirements. • Conduct periodic Data Integrity walkthroughs in Manufacturing, QC Laboratories, Warehouses, Utilities, Engineering, and other GMP areas. • Identify gaps related to ALCOA principles and drive appropriate CAPA implementation. • Perform periodic reviews of manufacturing and laboratory operations for Data Integrity compliance. • Support development of Data Governance processes, procedures, training programs, and awareness initiatives. • Monitor effectiveness of Data Integrity controls and remediation activities. • Participate in site and global Data Integrity forums to share best practices and continuous improvement initiatives. Investigations & Compliance • Participate in investigations related to Data Integrity concerns, compliance issues, and improper practices. • Conduct root cause analysis and support development of effective CAPAs. • Review CAPAs for adequacy, effectiveness, and timely implementation. • Verify effectiveness of corrective actions through follow-up assessments. • Prepare and present Data Integrity metrics, trends, and compliance reports for management review. Market Complaints Management • Manage receipt, evaluation, investigation, trending, and closure of product market complaints. • Coordinate cross-functional investigations and assess product quality impact. • Identify complaint trends and recommend corrective and preventive actions. • Ensure timely closure of complaints and associated CAPAs. • Support Annual Product Reviews, product recalls, field actions, and regulatory reporting activities, as applicable. Quality Compliance & Continuous Improvement • Support compliance initiatives related to Data Integrity, Market Complaints, CAPA, and Quality Systems. • Assist in regulatory inspections, customer audits, and inspection readiness activities. • Promote a culture of quality, integrity, and continuous improvement. • Participate in cross-functional projects to enhance compliance and product quality performance. 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