Ensure qualification documentation complies with GMP and regulatory requirements. Knowledge of GAMP 5 and 21 CFR Part 11. Strong Understanding of ALCOA principles.
Supervise and execute manufacturing activities in Granulation, Coating, Compression, and Capsulation as per cGMP and approved SOPs; Operate and monitor manufacturing equipment, ensuring proper batch setting, material handling, cleaning, and equipment performance, Amneal Pharmaceuticals
Ph.D. in any branch of biological sciences from any reputed university, and at least one first author research paper published in standard refereed journal as listed in Journal Citation Reports (JCR) of impact factor 3 or higher. Gujarat Biotechnology University
The objective of the Global Centre for Traditional Medicine (TMC) is to lead WHO's efforts to integrate traditional medicine into global health systems, ensuring safe, effective, and equitable access to traditional medicine practices with focusing on research and evidence, strengthening health systems, sustainability and equity, and innovation and technology.
To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India. Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.
Doctorate degree (Ph.D.) in a relevant discipline in the areas of Pharmaceutical Sciences/ Biological Sciences/ Environmental Sciences/ Agricultural Sciences/ Biotechnology or any equivalent discipline, from a recognised University or Institute. National Innovation Foundation
Assist in day-to-day production activities as per SOPs. Conduct basic chemical handling, mixing, and batch processing.
Monitor production processes and record process parameters.