Bachelor degree in a relevant field, such as Life Sciences or Healthcare. Proven experience in clinical data management within the pharmaceutical or biotechnology industry. ICON plc
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
Develop, maintain, and update laboratory systems and documentation, including SOPs, IQ/OQ/PQ documents, training records, and related quality documents.
Granules India is a vertically integrated, high-growth pharmaceutical company with 38 years of proven performance and increasing performance and increasing presence across the world.
Review QMS documents, SOPs, processes and records for compliance with GMP requirements; Support OOS, OOT, deviations, change controls, CAPA, risk assessments and investigations; Ensure compliance with ALCOA+ data integrity principles
Solid organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
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.