Deputy Manager Qa Validation Satari

Role & responsibilities

Validation Management Prepare, review, approve, and execute:

Validation Master Plan (VMP)

Equipment Qualification (DQ, IQ, OQ, PQ)

Process Validation (PV/PPQ)

Cleaning Validation

Hold Time Studies

HVAC Qualification

Water System Validation (PW/WFI)

Compressed Gas Validation

Computer System Validation (CSV)

Ensure lifecycle validation approach as per regulatory expectations.

Aseptic Process Validation Lead media fill simulations and aseptic process validation activities. Ensure compliance with sterile manufacturing guidelines and contamination control strategies. Monitor validation activities related to sterilization systems, autoclaves, and aseptic filling operations.

Documentation & Compliance Review and approve protocols, reports, SOPs, and qualification documents. Ensure ALCOA+ and data integrity compliance in all validation records. Maintain validation schedules, traceability matrices, and annual validation plans.

Regulatory & Audit Support Support all regulatory audits. Prepare responses for audit observations related to validation activities. Ensure inspection readiness of validation documentation.

Quality Systems Handle Change Control, Deviations, CAPA, Investigations, and Risk Assessments. Perform impact assessment of changes affecting validated systems. Participate in QRM/FMEA activities. Apply on Kit Job: kitjob.in/job/4n3d70