Analysis of Raw Material, In-process, Finish Products, Stability Tastings, Process Validation, Participate in Lab incident/OOS/OOT/Analytical Deviation.
Advanced degree, Masters or above in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science field. Strong experience in CMC Regulatory Affairs within pharmaceutical industry or research organization.
Experience in HPLC, GC, Dissolution, UV, TOC, and Sterility Testing. Hands-on expertise in analytical method development and validation. Aculife Healthcare
M.Sc/ B.Pharm / M.Pharm. To plan, prepare and review of high quality dossier with support and guidance, assuring technical concurrency and regulatory compliance, meeting agreed upon timeline.