Senior Executive, IPQA EM

Role Overview: You will be responsible for ensuring compliance with cGMP and regulatory requirements in the manufacturing and packaging shop floor. Your main duties will include performing in-process quality assurance activities such as real-time monitoring, documentation review, sampling, and area/machine clearances to support the production of high-quality injectable pharmaceutical products. Key Responsibilities: - Reviewing cGMP and compliance in manufacturing and packing areas - Supervising dispensing activities in the shop floor and packing areas - Issuing Bottle labels, Ouster, and Medication guides for commercial batches - Providing machine and area clearances - Conducting sampling of reserve samples, stability samples, and in-process checks during batch packaging execution - Reviewing online documents and records including equipment logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration records, batch records, etc. - Performing calibration of IPQA instruments - Real-time monitoring and compliance reporting - Participating in investigations - Providing on-the-job training to shop floor personnel on GMP practices, quality standards, and documentation practices - Maintaining IPQA-related documents and records in a state of audit readiness - Demonstrating good written and verbal communication skills in the English language Qualifications: - Education: Master's Degree (MS/MA) or M. Sc in Microbiology Experience: - 2 to 4 years of experience in In-Process Quality Control (IPQC) Skills: - Mastery in In-Process Quality Control (IPQC) - Advanced knowledge of Compliance and Regulatory requirements - Advanced skills in Aseptic Process Monitoring & Compliance - Mastery in Line Clearance & Batch Record Review - Advanced expertise in Deviation, Investigation & CAPA Management - Advanced proficiency in In-Process Checks & Monitoring - Advanced knowledge of Deviation & Change Control Management - Advanced understanding of Equipment & Facility - Advanced skills in Investigation for Root Cause Analysis - Advanced proficiency in Analytical Quality Assurance,