Masters of Science with about 22 years experience in Pharmaceutical / API Industries.
In-depth knowledge and Experience in area of Manufacturing, Scale-up, Technology transfer, Qualifications, Validations, Quality Assurance and Regulatory Affairs.
Strong leadership with good analytical and implementation skill. A team player leading from the front.
Specialties: Establishment of new API manufacturing facility right from all Qualification stages to Process Validation.
Plant operation in Regulatory environment, Process Optimization, Trouble shooting and Safety.
Successfully faced 4 Regulatory audits which includes USFDA, TGA and MOH.
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