Associate Manager - Quality Compliance

Pfizer — India - Vizag

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 i

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