Executive - IPQA cum Qualification/Understanding of Eng QA

Role & responsibilities

• Shop floor experience is required in the Tablets and Capsules section and sound knowledge of solid oral equipment functioning and operating principle
• Perform real-time monitoring of manufacturing and packaging processes to ensure adherence to GMP, SOPs, and regulatory requirements.
• Conduct in-process checks for critical quality attributes (e.g., weight, hardness, uniformity, and packaging integrity) at defined stages of production.
• Ensure timely documentation and approval of batch manufacturing records (BMR) and batch packaging records (BPR).

• Lead and coordinate qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and utilities.
• Develop and review qualification protocols and reports, ensuring compliance with engineering and quality standards.
• Support the validation of facilities, equipment, and systems, including HVAC, water systems, and compressed air systems.

• Collaborate with the engineering team to ensure equipment and systems meet quality and regulatory requirements.
• Perform risk assessments for engineering processes, focusing on critical quality aspects during design and operational phases.
• Support maintenance and calibration activities by verifying adherence to predefined quality standards and documentation requirements.