QA Executive – Validation (Injectables)

KeyBiz Dashboards Pvt Ltd; Hyderabad; On-site; INR 500,000 - 800,000; Full time

Job summary

KeyBiz Dashboards Pvt Ltd in Hyderabad is looking for a Validation Specialist to execute and monitor validation activities in sterile injectable manufacturing. You will prepare and maintain validation protocols, coordinate process validations, and ensure compliance with cGMP and regulatory guidelines. Collaboration with Production, Engineering, QC, and Microbiology departments is essential. The role is vital for maintaining data integrity and managing any deviations or audits!

Qualifications

• Experience in validation activities for sterile injectable manufacturing processes.
• Knowledge of cGMP, SOPs, and regulatory guidelines.
• Familiarity with HVAC and water system validation.

Responsibilities

• Execute and monitor validation activities for sterile injectable manufacturing.
• Prepare, review, and maintain validation protocols and reports.
• Coordinate process validation and media fill activities.

Job description

• Execute and monitor validation activities for sterile injectable manufacturing processes.
• Prepare, review, and maintain validation protocols and reports.
• DQ, IQ, OQ, and PQ for equipment and utilities
• HVAC validation
• Water system validation
• Compressed air and nitrogen validation
• Coordinate process validation and media fill activities.
• Perform cleaning validation and hold time studies.
• Ensure compliance with cGMP, SOPs, and regulatory guidelines.
• Review validation documentation and ensure proper data integrity practices.
• Coordinate with Production, Engineering, QC, and Microbiology departments.
• Handle deviations, change controls, CAPA, and risk assessments related to validation.
• Support internal audits and regulatory inspections.
• Maintain validation master plans and schedules.