Quality Assurance (Qualification & Validation) - Assistant Manager

Roles & Responsibilities : Qualification & Validation – Injectables

Plan, execute, review, and approve

Equipment, Utility, Facility, and Process Qualification & Validation

activities for injectable manufacturing operations in compliance with cGMP and regulatory requirements. Prepare, review, and approve

Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

protocols and reports. Perform and oversee

equipment qualification & validation

for sterile manufacturing systems, including but not limited to: Vial filling lines Ophthalmic filling lines Pre-Filled Syringe (PFS) lines Manufacturing vessels Autoclaves, Dry Heat Sterilizers, and Depyrogenation Tunnels Lyophilizers (where applicable) Ensure qualification and validation of

critical utilities and systems

, including: HVAC systems Purified Water (PW) systems Water for Injection (WFI) systems Pure Steam systems Compressed Air and Nitrogen systems Review and approve validation activities related to

Process Validation, Cleaning Validation, and Aseptic Process Simulation (Media Fill)

. Develop and implement

risk-based validation strategies

in alignment with regulatory guidelines and industry best practices. Evaluate and ensure timely

re-qualification and re-validation

of equipment, utilities, and processes based on change control, periodic review, and regulatory requirements.

Requirements: M. Pharma / B. Pharma with 10 – 15 years of hands-on experience in injectable qualification and validation activities with USFDA regulatory exposure.