Sr. Executive - Quality Assurance

Job Summary

• Responsible for coordinating, executing, reviewing, and maintaining validation and qualification activities for facilities, equipment, utilities, processes in compliance with GMP requirements.
• Responsible for handling of IPQA activities.

Key Responsibilities

• Preparation and review of equipment and utility qualification protocols, reports, and supporting documents, including HVAC, water systems, compressed air, and chillers.
• Ensure validation documentation complies with GMP, EU GMP, WHO GMP, Schedule M, and applicable regulatory requirements.
• Maintain validation protocols, reports, schedules, and qualification records.
• Coordinate temperature/humidity mapping, differential pressure verification, and other facility qualification activities.
• Prepare and review process validation protocols and reports.
• Establish and maintain periodic requalification schedules.
• Conduct validation-related risk assessments.
• Perform line clearance and in-process checks in manufacturing and packing activities.
• Review BMRs, BPRs, logbooks, checklists, and other manufacturing records for completeness and compliance.
• Identify and document process deviations.
• Coordinate and perform sampling of in-process, finished products, and validation samples as per approved procedures.
• Review IPQA-related documentation and ensure all required checks are completed before batch release.

Skills and Competencies

• Strong knowledge of GMP, EU GMP, WHO GMP, Schedule M, and applicable regulatory requirements.
• Good understanding of the qualification lifecycle, including DQ, IQ, OQ, PQ, and equipment qualification principles.
• Ability to prepare, review, and execute validation protocols, reports, risk assessments, and qualification documents.
• Good knowledge of change control, deviation, CAPA, and risk assessment.

Job Details

• Location : Bangalore
• Employment Type : Full-Time
• Experience : Not Specified
• Department : Validation / IPQA

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.