Pharmaceutical professional with 12 years of experience in FDA regulated Laboratory and manufacturing facility, including CRO and CMO. In-depth knowledge of cGMP, FDA, ICH guidelines and regulatory compliance procedures.Excellent scientific and technical knowledge of ANDA and NDA submission requirements.Experienced in managing and planning projects from pre-clinical to commercial.Experienced in authoring SOPs, batch records, validation protocols, and reports.Proficient in LIMS, EDMS, Trackwise, and other change control documentation procedures.Expertise in development and validation of analytical methods for small and large molecules in variousdosage forms (Softgels, sterile injectibles, Inhalation powders, Tablets)