Production - Sterile - Officer
USV · Daman · onsite · Posted 1d ago
Not disclosedFresherfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Production Sterile: Autoclave – Officer
- Sterilization Operations Supervision: Direct and supervise daily moist-heat sterilization cycles (autoclaves) and dry-heat sterilization/depyrogenation tunnels for equipment parts, garments, tubing, and glass containers.
- Sterilization Recipe & Cycle Management: Program, verify, and monitor validated sterilization cycles (gravity, prevacuum, air-overpressure), ensuring critical parameters ( $F_0$ values, dwell time, temperature, and pressure) are consistently met.
- Aseptic Load Transfer Oversight: Enforce strict aseptic unload protocols for transferring sterilized items from double-door autoclaves directly into Grade A/B cleanroom processing cores.
- BMR & Sterilization Log Verification: Execute and review real-time Batch Manufacturing Records (BMR), autoclave cycle printouts, temperature/pressure recorder charts, and equipment logbooks adhering to ALCOA+ data integrity standards.
- Sterility Assurance & Indicator Testing: Coordinate physical, chemical, and Biological Indicator (BI) placement and retrieval for load release, managing incubation tracking alongside Quality Control (QC).
- Equipment Qualification & Thermal Mapping: Coordinate quarterly and annual re-qualification activities, including thermal mapping, heat distribution/penetration studies, and Bowie-Dick steam penetration testing with Validation and Engineering teams.
- Line Clearance & Sanitization Enforcement: Perform and sign off on Type A/B line clearances, equipment surface sanitization, and chamber leak testing prior to initiating sterilization runs.
- QMS Investigation & RCA Lead: Initiate and lead shop-floor QMS tasks, investigating autoclave cycle deviations, sterilization failures, $F_0$ non-conformances, and implementing assigned CAPA measures.
- Audit Representation (EU Annex 1): Act as the front-line Subject Matter Expert (SME) during internal and regulatory audits ( USFDA, EU Annex 1, WHO ), presenting sterilization logs, load patterns, and BI challenge records.
- EHS & Pressure Vessel Safety: Enforce steam plant safety protocols, monitor pressure safety valve calibrations, ensure proper thermal PPE usage, and maintain workplace 5S discipline across the sterilization area.
Sourced from foundit
Skills
Audit RepresentationAseptic Load Transfer OversightBowie-Dick steam penetration testingDry-heat sterilizationEHS Pressure Vessel SafetyLine Clearance Sanitization EnforcementQMS Investigation RCASterility Assurance Indicator TestingSterilization Operations SupervisionSterilization Recipe Cycle ManagementEquipment QualificationMoist heat sterilizationThermal mapping
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
Find them on