01 Oct
|
Pfizer
|
Visakhapatnam
01 Oct
Pfizer
Visakhapatnam
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 positive 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
📌 Associate Manager (Visakhapatnam)
🏢 Pfizer
📍 Visakhapatnam