Senior Executive

Summary/ Overview:

• 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, Utility (HVAC, Water system, Compressed Air, Chillers qualification protocols, reports, and supporting documents.
• 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.
• To perform a 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, 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 qualification lifecycle i.e., 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.
• Good communication and teamwork.

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