Executive - IPQA cum Qualification/Understanding of Eng QA

Job Description

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.