Job Title

Key Responsibilities 1. Equipment Qualification Preparation and execution ofDQ, IQ, OQ, PQprotocols for injectable equipment. Qualification of equipment such as: Vial Washing Machine Depyrogenation Tunnel Vial Filling Machine PFS Filling Line Ophthalmic Filling Line Autoclaves & Sterilizers Vessels / Manufacturing Tanks Water System (PW/WFI) HVAC System Cleanroom Validation Activities 2. Process Validation Planning and execution ofProcess Validation (PV)for injectable manufacturing operations. Preparation of PV protocols, sampling plans and reports. Coordination with production, QC and engineering teams for PV execution. 3. Cleaning Validation Preparation and review ofCleaning Validation protocols and reports . Cleaning validation for product changeover, equipment cleaning, and CIP/SIP systems. Calculation of MACO, limits, and evaluation of cleaning effectiveness. 4. Documentation & Compliance Preparation, review and control of validation documents such as: Validation Master Plan (VMP) Qualification protocols and reports Deviations, Change Controls, Risk Assessments SOPs related to validation activities Ensure compliance withcGMP, USFDA, EU-GMPguidelines. 5. Investigation & Deviations Handling of deviations observed during qualification and validation. Support CAPA implementation and closure. 6. Audit Support Support internal, customer and regulatory audits. Provide validation documentation during inspections.