The role holder is responsible for supervising and executing the manufacturing operations for Compression, Encapsulation, Coating, and Packing sections in a highly regulated pharmaceutical environment.
To manage and support European regulatory activities for medicinal products across the EU lifecycle, including new registrations, variations, renewals, and regulatory maintenance, while coordinating with EU CMOs, MAHs, and regulatory authorities to ensure full compliance with EU legislation.
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