Senior Officer, Manufacturing Injectables at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

25 Jun, 26

Salary

0.0

Posted On

27 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Moist Heat Sterilization, F0 Calculation, SAL Concepts, Load Configuration, Parts Washers, Vial Washers, Depyrogenation Tunnels, Stopper Processors, Steam Quality, Vacuum Leak Tests, cGMP, Annex 1, US FDA Expectations, Data Integrity, ALCOA+, Deviation Handling

Industry

Pharmaceutical Manufacturing

Description

Key Responsibilities:- Supervise autoclave sterilization cycles for components, equipment parts, and solutions as applicable- Plan and monitor load patterns, cycle parameters, and F0; perform pre-run leak test/Bowie–Dick where applicable- Oversee component preparation systems: parts washer, vial washer, depyrogenation tunnel, stopper processor- Ensure component cleanliness, dryness, and bioburden/endotoxin control prior to sterilization- Coordinate routine maintenance/calibration for sensors, recorders, and safety interlocks- Review sterilization records, charts, and batch documentation; ensure ALCOA-compliant data- Support qualification (IQ/OQ/PQ), temperature mapping, and periodic requalification activities- Handle deviations, investigations, CAPA, and change controls related to sterilization and component prep- Train operators on correct loading, wrapping, sealing, and post-sterilization handling- Drive improvements in cycle robustness, throughput, and component preparation right-first-time Technical / Functional Skills:- In-depth knowledge of moist heat sterilization, F0 calculation, SAL concepts, and load configuration- Experience with parts washers, vial washers, depyrogenation tunnels (250–320°C), and stopper processors- Understanding of steam quality (dryness fraction, non-condensable gases) and vacuum leak tests- Knowledge of BI/CI usage, placement, and acceptance criteria; temperature mapping and data loggers- Familiarity with component preparation for aseptic lines (siliconization, tray alignment, transfer)- cGMP, Annex 1, US FDA expectations, and data integrity (ALCOA+) mastery Behavioral Competencies:- Ownership, discipline, and a strong compliance mindset- Ethical behavior, honesty, and accuracy in documentation- Clear communication and cross-functional coordination- Ability to coach operators/technicians and manage shifts- Structured problem-solving and calm decision-making on the floor Injectables–Specific Expectations:- Demonstrated success managing autoclaves and component preparation end-to-end- Awareness of endotoxin control and depyrogenation validation for glassware- Ability to support audit queries and present sterilization evidence confidently

Responsibilities

The Senior Officer will supervise autoclave sterilization cycles for components and equipment, overseeing preparation systems like parts washers and depyrogenation tunnels to ensure component cleanliness and bioburden control. This role involves reviewing sterilization records, handling deviations and CAPAs, and training operators on correct sterilization and post-sterilization handling procedures.