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