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, trainees, and technicians on aseptic core discipline.

📌 Production Sterile Sr Officer Daman
🏢 USV PRIVATE
📍 Daman