Quality Assurance Validation Executive

Job Summary

The QA Validation Executive is responsible for planning, execution, review, and documentation of validation and qualification activities in compliance with GMP and regulatory requirements. The role ensures that all manufacturing processes, equipment, utilities, and cleaning procedures for small volume injectables are validated and maintained in a validated state. The position plays a key role in ensuring product quality, sterility assurance, and regulatory compliance within the manufacturing facility.

Responsibilities

• Preparation, review, and execution of validation protocols and reports (IQ, OQ, PQ).
• Equipment qualification and process validation for injectable manufacturing.
• Cleaning validation to prevent cross-contamination.
• Validation of utilities such as HVAC, purified water, and compressed air systems.
• Aseptic process simulation (media fill) monitoring and documentation.
• Coordination with production, engineering, and QC teams for validation activities.
• Review of validation documents to ensure compliance with GMP and regulatory standards.
• Handling deviations, change controls, and CAPA related to validation activities.
• Maintaining validation master plan (VMP) and validation lifecycle.
• Ensuring audit readiness and supporting regulatory inspections.

Job Details

• Location: Neemrana
• Job Type: Full-time
• Experience: 3-5 years

Required Skills

• GMP compliance
• Validation protocols (IQ OQ PQ)
• Process validation
• Cleaning validation
• Equipment qualification
• Aseptic validation
• HVAC system knowledge
• Water system validation
• Data integrity (ALCOA+)