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.
- Valuable 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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📌 Senior Executive (Bengaluru)
🏢 Bioplus Life Sciences
📍 Bengaluru