Quality Assurance Manager having expertise in quality assurance functions of pharmaceutical and chemical industry from inception to completion while communicating horizontally and vertically in a highly regulated FDA/EU environment. Possess a background in both Fortune 500, entrepreneurial and start-up environments. Experienced in the followings: Overseeing the program at the site i.e. equipment/personnel qualification/validations etc. Periodic audits of the site to monitor compliance with established procedures and practices. Strong instrumental background in HPLC and GC, UV/VIS spectrophotometer, FTIR, NMR, DSC, NIR, AA, TOC analyzer and particle size analyzer. Strong interpersonal skills. Internal audits and HACCP certification Peoples developments, trained chemists and microbiologists cGMP/cGLP training, calibration of laboratory instruments, and audit expertise Performed the investigation and got it documented, and confirmed that the corrective actions were taken to prevent the recurrence of the problem (CAPA, Deviations and OOS). Also ensured any deviations from normal procedures were documented and justified.

Highlights:

• Quality
• Quality Assurance
• Quality Control
• Complaints
• Compliance
• Management
• Test
• Assessments
• Audit
• Corrective Actions