Associate Manager Quality Control

Pfizer; Visakhapatnam; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Pfizer in Visakhapatnam, Andhra Pradesh, India seeks an experienced analytical professional to lead method transfers, validations, and verifications for complex analytical techniques. The role emphasizes data interpretation, GMP/GLP compliance, and documentation maintenance to ensure product safety and efficacy.

The ideal candidate holds a Master’s in chemistry or pharmacy with 8–10 years of hands-on experience in analytical method transfer/validation, ICH Q2, USP/EP standards, and risk

Qualifications

• Master's degree in chemistry/pharmacy with 8-10 years of experience in Analytical Method Transfer/Validation
• Demonstrated ability to read/apply compendial methods, SOPs and regulatory standards
• Experience in ICH Q2, USP, EP validation protocols and crossfunctional coordination
• Familiarity with ICH Q9 risk management and CAPA processes
• Experience handling OOS/OOT cases within QMS and change controls

Responsibilities

• Perform method transfers, validations and verifications for complex analytical techniques
• Interpret data for accuracy, trends, and cGMP impact; recommend corrective actions
• Ensure documentation complies with GMP/GLP and filing policies
• Review and revise SOPs and analytical methods to keep them current
• Conduct analyses on finished products and materials with data entry and approval in databases
• Support project completion, plan work activities within a team under supervision

Skills

Analytical method transfer

Method validation

ICH Q2

GMP/GLP compliance

OOS/OOT handling

CAPA management

Risk management

Documentation control

Data analysis

Education

Masters degree in chemistry/pharmacy

Tools

HPLC (Empower)

GC

IC

ICP-MS

Potentiometry

UV-Vis

FTIR

Karl Fischer

pH meters

Job description

Job Description

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.

What You Will Achieve

In this role, you will:

• Perform method transfers/ validations / method verifications to the complex analytical techniques
• Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.
• Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.
• Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.
• Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database.
• Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.

Here Is What You Need (Minimum Requirements)

• Masters degree in chemistry/ pharmacy with 8-10 years of experience in Analytical Method Transfer / Validation)
• Qualified in multiple analytical techniques (HPLC-with Empower, GC, IC, ICP-MS, Potentiometry, UVVis, FTIR, Karl Fischer, and pH meters)
• Demonstrated technical skills in method validation and testing
• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
• Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards, encompassing protocol preparation, execution, approval of validation summaries, and coordination with crossfunctional teams.
• Conduct test method GAP assessments against USP, EP, BP, and JP requirements for New Product Introduction (NPI).
• Execute and document analytical method verification and method transfer activities.
• Demonstrate knowledge of ICH Q9 (Quality Risk Management) and apply riskbased principles for identifying, assessing, controlling, communicating, and reviewing quality risks throughout the product lifecycle.
• Handling of OOS and OOT through QMS.
• Perform identification, assay, purity, and related analytical tests using validated methods.
• Monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
• Support process validation and troubleshooting activities; communicate analytical results promptly to Production and QA to ensure effective process control.
• Manage working standards in compliance with established procedures.
• Handle change control activities and ensure timely implementation and closure of related CAPA actions.
• Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.
• Excellent organizational skills and strong ability to multi-task
• Strong written and verbal communication skills
• Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation

Bonus Points If You Have (Preferred Objections)

• Experience ..
• More…

Work Location Assignment:On Premise