PHARMAFull-time
Associate Manager - QA Review (CQ)
VIZAG (IN)ONSITEPOSTED: 8/15/2026
PHARMAFull-time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Analytical QA Review & Method Validation: Lead quality reviews for Analytical Method Validation (AMV), Analytical Method Transfer (AMT), and method verification across sterile dosage manufacturing quality control operations in adherence to ICH Q2 (R1/R2), USP, EP, BP, and JP standards.
Quality Risk Management & Investigations: Apply ICH Q9 risk-based principles to identify, evaluate, mitigate, and review quality risks across analytical processes; conduct technical investigations for OOS/OOT results and deviations using structured quality root-cause tools.
Change Control & Compendial Compliance: Perform thorough quality assessments for change controls, compendial monograph updates, and New Product Introductions (NPI) to ensure regulatory alignment.
Specialized Impurity & Safety Assessments: Review risk assessments and analytical testing strategies for Elemental Impurities (ICH Q3D), Nitrosamine impurities, and Extractables & Leachables (E&L).
Validation & Qualification Oversight: Review documentation for laboratory equipment qualifications, cleaning validations, process validations, HVAC, water systems, and facility utility qualifications.
Audit & Inspection Readiness: Participate in and support global regulatory authority inspections (such as USFDA, EMA, WHO) ensuring rigorous GMP compliance and data integrity standards.
Technical & Domain Standards
Comprehensive mastery of advanced analytical instrumentation including HPLC (Empower), GC, IC, ICP-MS, FTIR, UV-Vis, Karl Fischer, and AAS.
In-depth expertise in sterile manufacturing QA standards, cGMP, 21 CFR Part 11, data integrity principles, and pharmacopoeial compliance.
Total Rewards & Culture
Leadership role within Pfizer's state-of-the-art sterile manufacturing facility in Vizag.
Competitive multinational compensation package, performance incentives, and comprehensive corporate health and wellness benefits.
REQUIRED VERIFIED SKILLS
Quality Assurance
Analytical Method Validation
Analytical Method Transfer
ICH Q2
ICH Q9
Quality Risk Management
Change Control
HPLC
GC
ICP-MS
Sterile Manufacturing
Compendial Changes
OOS/OOT Investigations
COMPENSATION & REWARDS
₹12.0L - 20.0L per annum
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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