04 Sep
|
Pfizer
|
Visakhapatnam
04 Sep
Pfizer
Visakhapatnam
Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering protected 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
📌 Associate Manager (Visakhapatnam)
🏢 Pfizer
📍 Visakhapatnam