Job Summary
The Regulatory Validation Executive is responsible for planning, executing, reviewing, and maintaining validation activities to ensure pharmaceutical products, manufacturing processes, equipment, utilities, facilities, and computerized systems comply with regulatory requirements and quality standards. The role supports compliance with guidelines from organizations such as the US Food and Drug Administration, European Medicines Agency, and World Health Organization, as well as GMP requirements.
Key ResponsibilitiesValidation Activities
- Prepare, review, and execute validation protocols and reports.
- Perform:
- Equipment Qualification (IQ, OQ, PQ)
- Process Validation
- Cleaning Validation
- Utility Validation (HVAC, Water Systems, Compressed Air)
- Computer System Validation (CSV)
- Monitor validation schedules and ensure timely completion.
Regulatory Compliance
- Ensure compliance with GMP, GLP, and applicable regulatory guidelines.
- Maintain validation master plans (VMPs).
- Support regulatory inspections and customer audits.
- Assist in responding to regulatory observations and audit findings.
Documentation & Record Management
- Prepare and maintain validation documentation.
- Review batch records, SOPs, change controls, and validation-related documents.
- Ensure documentation follows data integrity requirements.
Risk Assessment & Investigations
- Participate in risk assessments related to validation activities.
- Investigate deviations, non-conformances, and out-of-specification results.
- Recommend corrective and preventive actions (CAPA).
Cross-Functional Coordination
- Coordinate with Production, Engineering, Quality Control, Microbiology, and Regulatory Affairs departments.
- Provide validation-related technical support during new product launches
Pay: ₹9,934.91 - ₹32,905.33 per month
Benefits:
Work Location: In person
