Senior Technical Supervisor

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 clear-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.