Production Sterile: Aseptic – Senior Officer

• Aseptic Core Supervision: Lead daily aseptic filling, stopper insertion, capping, and lyophilizer loading operations inside Grade A/B processing suites to hit production targets safely.
• Aseptic Technique & Annex 1 Compliance: Enforce strict adherence to EU Annex 1 aseptic behavior guidelines, cleanroom airflow dynamics (LAF/RABS/Isolators), and multi-stage cleanroom gowning qualification.
• BMR Execution & ALCOA+ Data Integrity: Execute and verify real-time Batch Manufacturing Records (BMR) and equipment logbooks, maintaining strict adherence to ALCOA+ data integrity principles.
• Line Clearance & Aseptic Set-Up: Perform and sign off on Type A/B line clearances, aseptic setup of filling needles/tubing, and sterilization-in-place (SIP) / cleaning-in-place (CIP) routine verifications.
• Filter Integrity & In-Process Checks: Execute pre- and post-use bubble point / water intrusion filter integrity tests, perform line fill-weight adjustments, and supervise environmental sampling routines.
• Aseptic Process Simulation (Media Fills):



Participate in and help coordinate biannual Aseptic Process Simulations (Media Fills), managing shift schedules, interventions, and failure mode testing.
• QMS Investigation & RCA Lead: Initiate and drive shop-floor Quality Management System tasks, leading Root Cause Analysis (RCA) for aseptic interventions, environmental excursions, deviations, and CAPA execution.
• Equipment Qualification & Validation: Support floor execution of equipment qualifications (IQ/OQ/PQ), thermal mapping, velocity matrix checks, and cleaning/sterilization validation protocols.
• Audit SME Representation: Act as a front-line Subject Matter Expert (SME) during internal and regulatory audits (USFDA, EU Annex 1, WHO), presenting aseptic filling records and room intervention logs.
• EHS, 5S & Team Guidance: Enforce cleanroom Environmental Health & Safety (EHS) policies, oversee 5S discipline, and mentor junior officers,

📌 Production - Sterile - Sr. Officer (Daman)
🏢 USV Private
📍 Daman