CQV Engineer / Process Engineer (Delhi-NCR)

Hector & Streak Consulting Pvt Ltd – Date posted: 30 Sep 2015
Validation Experience in Bio-Pharmaceutical Industry Ability to manage, lead, and mentor direct and indirect employees Deep understanding of quality by design principles and ASTM 2500 requirements.

Ability to develop, review, approves, and executes QV documentation and protocols (Risk assessments, IOQ, FAT/ SAT, etc.) Prefer experience with API, Upstream and Downstream processes, Formulation/ Filling/ Inspection, Isolators, cleaning validation programs, and clean utilities Deep knowledge of current FDA and EMEA regulations and demonstrated compliance to these requirements Development of standards and guidelines for Qualification and Validation programs….

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