Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP.
Responsible for review of URS, DQ and vendor/ supplier’s documents related to qualification.
Responsible for preparation and review of Validation/ Qualification protocol and report.
Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities.
Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective
Qualification / Validation / Re-qualification activity for timely completion of activities.
Responsible for preparation and review of media fill and hold time protocol and report.
Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system
B.Pharm / M. Pharm / M.Sc
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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