Associate Manager - Quality Compliance

Pfizer; Visakhapatnam; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Pfizer Vizag is seeking an Associate Manager - Quality Compliance to strengthen Data Integrity, CAPA and regulatory readiness in a fast-paced GMP environment. You will partner with site teams to ensure ALCOA-compliant data, manage investigations and drive continuous improvement.

The role covers market complaints, QA systems, and collaboration with global inspections, requiring 8–12 years experience in QA/compliance, preferably in sterile manufacturing, and a strong foundation in regulatory

Qualifications

• Bachelor's/Master's in Pharmacy or Life Sciences with 8–12 years in QA/compliance.
• Experience in regulated sterile manufacturing environments.
• Familiar with global regulatory inspections (FDA, EMA, WHO, etc.).

Responsibilities

• Lead Data Integrity governance and promote ALCOA principles across GMP areas.
• Manage investigations, root-cause analysis and CAPA closure.
• Oversee Market Complaints evaluation, trending and closure with cross-functional teams.
• Support regulatory inspections, audits, and inspection readiness activities.
• Drive continuous improvement in Quality Systems and compliance programs.

Skills

Data Integrity

Quality Assurance

CAPA

Regulatory Awareness

Root Cause Analysis

Cross-functional Collaboration

Education

Bachelor's or Master's in Pharmacy or Life Sciences

Tools

eQMS

Manufacturing Systems

Job description

## Associate Manager - Quality ComplianceApply: India - Vizag: Full time: Posted Today: 4965173**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