BA-BE Auditor 5

Pharmaceutical Formulation/Process Development, Technology Transfer, GMP site investigations, Developmental QA, MSAT, & Project Management of various dosage forms. Strong team player with 15 years’ experience in USA, EU, UK, Canada, Australia Regulated Markets. Formulation/Process Development and Technology Transfer to cGMP sites (Sterile Oncology and Non. Oncology Dosage forms) by QBD, DOE approach for US, EU, UK, Canada, AUS Markets. Portfolio Management, Leadership Skills, SPA for projects and transfer. Lean and Six Sigma Green Belt Certified. Lyophilization cycle development and SME for Lyo network Preparation and review of Technical/Scientific Protocols, Reports and Specifications; Product Development, Stability, Compatibility, Filter validation, cleaning validation, Batch Manufacturing Record, Sampling protocol for Pilot scale, Exhibit batch and commercial batches. Providing Technical services and monitor global CRO’s, CMO’s, Stability Labs. Investigated Sterile Manufacturing and R&D deviations/NCs and fixed CAPA to meet compliances. Handle Drug product Life Cycle Management and performed technical assessment to meet current product quality by Risk Assessment, Quality Target Product Profile (CPP, CQA), predict stability trend using Minitab stat tool, Lean and Six Sigma, continuous improvement. Strategic critical thinker with strong analytical and communication skills, Self-motivated, effective CFT collaboration with decision making skills. Involved in USFDA, PICs audits and budget allocation, equipment validation. Ok with any country. Also ok for Middle east countries. Asian (Singapore, Indonesia, Malaysia, Philippines, Japan, Taiwan, China, etc.) UK, Europe, USA, AUSNZ etc. Can speak and write English and Tamil fluently. Speak and write Malay, Bahasa Indonesia, can speak Hindi, Telugu and Malayalam. Based in Chennai, India.