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

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