Associate Manager - QA Review (CQ)

About the Company

PHIPL operates a manufacturing facility in Visakhapatnam dedicated to sterile injectables, including vials, emulsions, and ampoules. The site focuses on a patient-centric approach, ensuring high-quality standards supported by integrity and strict compliance.

Role Summary and Responsibilities

The Associate Manager role requires a Master's degree in chemistry or pharmacy with 8-10 years of experience in analytical method transfer, validation execution within quality control laboratories, and quality review for sterile dosage manufacturing environments. Key responsibilities involve management and execution of analytical method validation, method transfer, verification, and documentation review aligned with industry standards.

Technical Expertise

• Perform analytical method validation and transfer activities following ICH Q2 (R1/R2), USP, and EP guidelines.
• Utilize various analytical techniques including HPLC (Empower), GC, IC, ICP-MS, potentiometry, UV-Vis, FTIR, Karl Fischer, AAS, XRF, NIR, and pH meters.
• Execute laboratory tests such as identification, assay, purity, and related analyses with validated methods.
• Assess and interpret data against procedural and compendial requirements including USP, EP, BP, JP standards.
• Conduct risk assessments and implement quality risk management principles per ICH Q9.
• Understand and manage change control processes, regulatory and compendial updates, and stability management.
• Reference knowledge in elemental impurities, nitrosamine impurities, extractables & leachables, and their regulatory guidelines.
• Possess familiarity with process, cleaning, analytical method validations, water system, HVAC, equipment, and utility qualifications.
• Handle documentation with clarity, accuracy, and completeness to meet organizational needs.
• Experience in regulatory inspection handling and compliance with GMP standards.

Behavioral and Managerial Skills

• Communicate effectively across all organizational levels and cultivate constructive working relationships.
• Demonstrate persistence and effective problem-solving abilities in managing issues.
• Make timely decisions using available information and maintain a proactive approach.
• Maintain strong scientific and analytical reasoning with attention to detail and data integrity.
• Exhibit leadership, mentoring, and collaboration skills for cross-functional teamwork.
• Develop self-awareness and pursue individual development goals.
• Showcase excellent documentation, investigation, and stakeholder management capabilities.