Key Responsibilities:-
Lead day-to-day operations on isolator-based cartridge filling lines- Ensure readiness of filling lines, line clearance, and coordination with QA/Engineering- Drive qualification & validation activities: equipment qualification, media fills, process simulations- Review batch documents, deviation investigations, CAPA, and change controls- Ensure in-process controls: fill volume, crimp integrity, torque, visual checks- Lead investigation teams for any filling-related process failures
Technical / Functional Skills:- Strong understanding of isolator/RABS-based filling systems- Expertise in qualification activities: URS, DQ, IQ, OQ, PQ- Hands-on knowledge of media fills, VHP cycles, and glove integrity testing- Understanding of CCS (Contamination Control Strategy) requirements- Able to interpret SCADA/BMS/HMI data for troubleshooting
Behavioral Competencies:- Strong leadership and decision-making abilities- Excellent communication and stakeholder management- High compliance and documentation discipline
Injectables–Specific Expectations:- Experience handling cartridge filling lines in isolator environment- Understanding of regulatory expectations (USFDA, EMA, WHO)- Ability to lead validation and requalification cycles
Experience: 10–12 Years (Sterile Injectables)
Qualification: B.Pharm / M.Pharm (Mandatory)
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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