PHARMAFull-time
Associate Manager - Quality Assurance
AHMEDABAD (IN)ONSITEPOSTED: 8/22/2026
PHARMAFull-time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Maintain overall responsibility for Quality Assurance (QA) compliance at the Zydus Hospira Oncology Private Limited (ZHOPL) site to ensure sustainable GMP compliance for Pfizer products per Quality Agreements.
Perform batch record review and authorization functions, including authorization of packed batch lot(s) for market distribution and participation in the Site Quality Review Team (SQRT) for batch-related discussions.
Conduct regulatory impact assessments for changes related to Pfizer products, and review and approve Change Controls at ZHOPL per Pfizer standards.
Execute Site Compliance Network Member (SCNM) activities at ZHOPL, creating Post-Approval Change (PAC) and Post-Approval Commitment Tracking (PCF) entries in PDM systems.
Review and approve submission packages according to procedure REG-459, review Board of Health (BoH) queries and responses, and manage compendial/scientific data changes.
Oversee complaint management for Pfizer products by reviewing and approving ZHOPL investigation reports and uploading them into the Pfizer electronic complaint database.
Coordinate during market actions and mock recall activities, assisting Pfizer market action leader functions and sharing relevant distribution details.
Assist with supplier quality management activities for active pharmaceutical ingredients (APIs), excipients, and critical processing aids per Pfizer Quality Standards.
Support Quality Management System (QMS) compliance, including review and approval of site-initiated Quality Action Reports (QARs), process validation documentation, and document reviews for new product launches (NPL) and tech transfers.
Technical & Domain Standards
Ensure strict compliance with current Good Manufacturing Practices (cGMP) and global Pfizer Quality System regulations across manufacturing, packaging, and validation workflows.
Manage Pfizer digital platforms, electronic databases, and SharePoints for tracking Change Controls, Investigations, Complaints, and Supplier Quality.
Apply statistical, mathematical, and probability concepts to Quality Engineering and process validation tasks.
Leadership & Impact
Participate as a core decision-maker in SQRT meetings to resolve critical batch issues and quality investigations.
Lead training management initiatives for the team, assessing, reviewing, and implementing Global Standard Operating Procedures (GSOPs) at the site level.
Serve as the operational compliance liaison between ZHOPL manufacturing facilities and Pfizer's global quality network.
Benefits & Total Rewards
Competitive corporate salary package complemented by incentive plans and standard pharmaceutical industry perks.
Comprehensive health insurance, wellness support, and continuous professional learning opportunities within a global biopharmaceutical leader.
REQUIRED VERIFIED SKILLS
Quality Assurance
cGMP Compliance
Batch Release
Change Control
Quality Management System (QMS)
Complaint Management
Regulatory Impact Assessment
Supplier Quality Management
Tech Transfer
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation. It is dedicated to the discovery, development, manufacturing, marketing, and sale of medicines and vaccines worldwide. The company focuses on breakthrough science to deliver innovative treatments across various therapeutic areas to improve health outcomes.
TEAM SIZE: 80,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare
RECOMMENDED TRAINING
1/5
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