Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – US, Canada, Europe, Australia
A Scientific Professional with Bachelor, Masters degree in Pharmacy, Life Sciences, Chemistry, Biological Sciences with a business management degree, MBA is preferred. A minimum of 9 years experience with at least 5 years in a technical field analytical background and at least 4 year of experience in a customer facing role.
Co-ordination with product development team to keep track of various projects. Sample seeding from suppliers for project initiation. Co-ordination with supplier, principle for arranging quality documents.
Exposure in investigation of UPD , OOS, OOT, EM and Change control & CAPA Management. Preferable for exposure in Regulator}’ and FDA Audits, Knowledge and exposure for aseptic operations and principal of its relevant equipment.
2-7 years of experience in production planning, change control, line clearance, deviation handling, autoclave operation TS and component, aseptic and control area operation, documentation, both SVP and LVP manufacturing etc.
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. Headquartered in Hyderabad, India, Granules offers collaborative and strategic partnership to global pharmaceutical leaders by producing best quality API, PFI and FD through manufacturing excellence, process innovation and regulatory expertise.
WALK IN INTERVIEW Production, Warehouse, Engineering & IPQA (OSD Formulations)
Respond to medical information requests from internal and external customers and ensure the responses are medically and scientifically accurate, timely, balanced, and meet customers’ needs.
Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including R&D, Product Management, Quality, Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips market organization.
B. Pharm, M. Pharm, B.Tech. experience supervising and controlling production areas like Aseptic Filling, Vial Washing, Autoclave and Lyophilizer. Exposure of machine qualification activity will be added advantage.