1.0 Major Job Responsibilities • Supervise On-Floor IPQA Operations: Oversee day-to-day In-Process Quality Assurance (IPQA) monitoring across manufacturing blocks (Formulation, Core Processing, Filling, and Packaging) to ensure real-time operations strictly mirror validated parameters. • Execute Line Clearances and Stage Gate Releases: Formally audit, verify, and sign off on multi-stage line clearances (major/minor) between batches, lots, and product changeovers, authorizing production lines to start. • Conduct Scheduled Floor Audits: Lead routine, unannounced walkthroughs of manufacturing cabins and packaging halls to verify room status, calibration tags, environmental monitoring plates, and aseptic compliance. • Oversee Sampling Operations: Monitor and verify the collection of in-process control (IPC) samples, validation samples, blend uniformity samples, and composite finished product samples by IPQA personnel. • Resource Allocation & Team Management: Manage shift schedules, roster allocations, and work distribution maps for on-floor IPQA officers based on manufacturing priorities and plant capacities. • Review Variable Print & Aggregation Setups: Formally check and authorize variable data setups (Batch Number, Expiry, Serialization codes) on primary, secondary, and tertiary packing lines prior to batch commercial processing. ________________________________________ 2.0 Quality & cGMP Responsibilities • Enforce Strict cGMP & Data Integrity Compliance: Drive absolute shop-floor compliance with global regulations (US FDA, EU GMP Annex 1, MHRA) and ALCOA+ data integrity principles; verify that records are filled out concurrently. • Review Batch Manufacturing Records (BMR/BPR) in Real Time: Review running logbooks, process parameter printouts, critical control step records, and IPC charts on the floor to catch errors or gaps prior to batch closure.



• Lead First-Line Deviation Management: Serve as the immediate Quality contact on the floor for process disruptions, equipment alarms, and out-of-specification (OOS) physical targets; initiate deviation reports and execute immediate containment actions. • Support Manufacturing Validation Studies: Audit and verify parameters during the execution of process validation batches, media fills, hold-time studies, and automated packaging qualifications. • Maintain Continuous Audit Readiness: Enforce an ongoing state of compliance on the shop floor, preparing operations, logs, and workers to interface confidently as subject matter experts during regulatory inspections. ________________________________________ 3.0 Environment, Health, & Safety (EHS) Responsibilities • Enforce Facility PPE Mandates: Verify and mandate that all IPQA staff and production personnel rigorously utilize the required Personal Protective Equipment (cleanroom gowns, PAPR, safety shoes, safety glasses, hearing protection) designated for specific zones. • Monitor Hazardous Area Controls: Confirm that high-containment controls, powder isolation split-valves, differential pressure gauges, and local exhaust vent shields are functioning perfectly prior to approving room operations. • Audit Lockout/Tagout (LOTO) and Work Permits: Audit the floor to ensure that all line transparent-downs, deep mechanical washdowns, or operator engineering entries follow correct LOTO safety steps. • Maintain Clear Safety Transit Corridors: Enforce strict housekeeping protocols to ensure that emergency exit pathways, fire extinguishers, and emergency eye-wash loops remain completely unobstructed by pallets, waste drums, or equipment boxes. • Report Floor Incidents Promptly: Report all near-misses, ergonomics hazards, structural cleanroom leaks, or chemical/powder exposures instantly to the area manager and the plant EHS team.

📌 Senior Technical Supervisor (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka