Associate Manager - Quality Control
By Admin · Quality Assurance & Quality Control
ROLE OVERVIEW
This Associate Manager Quality Control role at Pfizer's Vizag (Visakhapatnam) site sits at the heart of the company's mission to deliver safe, effective medicines. As a senior analytical QC professional, you will lead method transfers, validations, and verification activities for complex techniques while ensuring cGMP/GLP compliance across finished products, raw materials, and components. The position directly supports Pfizer's commercial pipeline by safeguarding product quality, enabling new product introductions, and maintaining regulatory inspection readiness. For candidates with deep HPLC, GC, ICP-MS, and compendial expertise, this is a compelling opportunity to influence quality systems at a global biopharma leader, collaborate cross-functionally with Production and QA, and build a long-term career in pharmaceutical quality. The Vizag site offers hands-on exposure to ICH, USP, EP, and risk-based quality practices.
ROLE DEFINITION & RESPONSIBILITIES
- •Perform analytical method transfers, validations, and verifications for complex techniques, including protocol preparation, execution, and validation summary approval.
- •Interpret and evaluate analytical data for accuracy, precision, trends, and potential cGMP impact, recommending corrective actions when needed.
- •Conduct analyses of finished products, raw materials, and components, with data entry, review, and approval in computerized databases.
- •Review, revise, and maintain SOPs, analytical methods, and related quality documents to ensure current compliance.
- •Handle OOS/OOT investigations through the QMS, manage change controls, and ensure timely CAPA implementation and closure.
- •Monitor critical process parameters and critical quality attributes; communicate analytical results promptly to Production and QA.
- •Perform identification, assay, purity, and related tests using validated methods while managing working standards and sample retention.
- •Support process validation, troubleshooting, and test method gap assessments against USP, EP, BP, and JP for NPI.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master's degree in Chemistry or Pharmacy (M.Sc./M.Pharm) with 8–10 years in analytical method transfer/validation.
- Proven qualification in HPLC with Empower, GC, IC, ICP-MS, UV-Vis, FTIR, Karl Fischer, potentiometry, and pH meters.
- Hands-on expertise in analytical method validation, verification, and transfer per ICH Q2(R1/R2), USP, and EP.
- Ability to interpret compendial methods, SOPs, technical procedures, and government regulations.
- Working knowledge of ICH Q9 Quality Risk Management and cGMP/GLP documentation practices.
- Strong organizational skills, multi-tasking ability, and written/verbal communication for cross-functional coordination.
PREFERRED QUALIFICATIONS
- •Lean Manufacturing and Six Sigma Methodologies
- •Statistical Analysis for QC Trends
- •Continuous Improvement Project Leadership
- •Test Method GAP Assessments for NPI
- •LIMS and Computerized Database Proficiency
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
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.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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