Deputy Manager QA Validation (Goa)

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/4mswt6