Strong background and knowledge in manufacturing, compliance, and technology investigations, processes, and systems. Ability to work both independently and collaboratively.
Having Injectable Experience of Shop floor supervising activities like filtration, Filling, Sealing, Stoppering, Garment Washing, Vial Washing, Autoclave, Ophthalmic, Suspensions, Lyophilizes. Operations and Training and QMS.
Regulatory Affairs Executive is responsible contribute regulatory expertise in various aspects including regulatory submissions, right first-time dossiers, timely addressal of queries, etc. for various product categories such as Cosmetics, Commodities etc.
To drive end-to-end execution of new product launches for assigned geographies, ensuring timely delivery, commercial success, and alignment with revenue targets.
Experience in granulation, compression, capsule & coating oral liquid manufacturing areas of regulated markets. FDA approved personnel in tablet manufacturing would be preferred.
Lead Commissioning, Qualification & Validation activities for equipment, utilities, and computerized systems. Develop & approve IQ, OQ, PQ, cleaning validation, process validation, and CPV documentation.