Associate Manager - Quality Control

Responsibilities

• Perform method transfers, validations, and verifications using complex analytical techniques.
• Interpret and evaluate data for accuracy, precision, and trends to recommend corrective actions.
• Ensure all documentation and quality records comply with cGMP and GLP standards.
• Review and revise Standard Operating Procedures (SOPs) and analytical methods.
• Conduct analyses on finished products, raw materials, and components.
• Conduct test method GAP assessments against USP, EP, BP, and JP requirements for New Product Introduction (NPI).
• Monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
• Manage change control activities and ensure timely implementation of CAPA actions.

Requirements

• Master’s degree in Chemistry or Pharmacy.
• 5-7 years of experience in Analytical Method Transfer and Validation.
• Proficiency in multiple analytical techniques including HPLC (with Empower), GC, IC, ICP-MS, Potentiometry, UV-Vis, FTIR, Karl Fischer, and pH meters.
• Demonstrated ability to conduct method validation in accordance with ICH Q2, USP, and EP standards.
• Strong knowledge of ICH Q9 (Quality Risk Management) and risk-based principles.
• Deep understanding of cGMP and GLP compliance.
• Excellent organizational, multi-tasking, and communication skills.

Preferred Qualifications

• Proven track record in leading continuous improvement projects.
• Strong knowledge of lean manufacturing principles, Six Sigma methodologies, and statistical analysis.
• Advanced problem-solving skills and high attention to detail.
• Ability to manage multiple priorities and meet strict deadlines in a laboratory environment.

About the Company

Pfizer is a global leader in the pharmaceutical industry, dedicated to delivering safe and effective products to patients worldwide. Our culture is rooted in science, innovation, and a commitment to quality, aiming to transform lives through groundbreaking therapies.