DAMAN · FULLTIME
Production - Sterile - Sr. Officer
USV
Daman · onsite · Posted 7d ago
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Section · 01
About this role
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.
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Section · 02
Skills
5S disciplineEquipment qualification validationinternal and regulatory auditsAseptic Process Simulation Media FillsAseptic Set-UpFilter Integrity In-Process Checksline clearanceaseptic technique
Section · Company
About USV
USV
Pharma
7.1k+
employees
1961
65 years old
Mumbai, Maharashtra
India
About
USV India is the top old leading healthcare industry & pharmaceutical company in Mumbai, India. They provide API, Peptides, Biosimilars, Injectables, Ophthalmics & Solid Orals products in India
Industries
PharmaManufacturing
Employee ratings
1,753 reviews
4.0/ 5
Culture
3.8
Career growth
3.5
Work-life
3.8
Employees rate it well for
Work Culture220Salary137Senior Management115Work Environment110Appraisal91
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