Key Responsibilities:-
Supervise end-to-end operations on isolator-based cartridge filling, stoppering, and capping lines- Ensure batch readiness: component availability, line clearance, and area readiness in Grade C background- Execute/monitor VHP bio-decontamination cycles, leak tests, and glove integrity testing (GIT)- Oversee line setup/teardown, sterilized format parts handling, and aseptic connections via RTPs/ports- Monitor IPC checks (fill volume, weight, torque, crimp integrity) and document results in BMR- Coordinate with QA/Engineering for alarms, troubleshooting, and timely line restarts- Lead media fill preparations and execution support; ensure adherence to Annex 1 and site procedures- Review logbooks/BMRs, ensure ALCOA-compliant entries, and support deviations/CAPA- Ensure EM support during operations with minimal interventions- Drive continuous improvement in setup time, first-pass yield, and reject reduction
Technical / Functional Skills:- Hands-on experience with isolators or closed RABS cartridge filling lines- Working knowledge of VHP cycles and material transfer via pass-throughs- Knowledge of GIT, pressure differentials, airflow visualization, and Grade A unidirectional flow- Understanding of washer, depyrogenation tunnel, filling machine, stopper/capper systems- In-process controls: fill weight/volume checks, container closure integrity fundamentals- Strong grasp of cGMP, EU GMP Annex 1, US FDA expectations, and ALCOA+
Behavioral Competencies:- Ownership, discipline, and a strong compliance mindset- Ethical behavior and accurate documentation- Clear communication and leadership on the floor
Injectables–Specific Expectations:- Proven aseptic behavior in Grade A/B environments- Experience with media fills and CCS requirements- Capability to perform aseptic interventions inside isolator
Experience: 3–5 Years (Sterile Injectables)
Qualification: B.Pharm / M.Pharm
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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