Candidate should have knowledge of manufacturing operations of granulation, compression, coating and capsule filling, responsible to adherence cGMP guidelines.
Thoroughly analyze and critically interpret data to determine the best approach to composing each document. Participate in meetings related to key MW, QC, and compliance activities
PhD in Pharmacy with Minimum of 10 years Teaching and or Research and or Industrial experience of which at least 5 years should be at the level of Associate Professor having publications in reputed indexed journals.
VBPL is an ISO 13485:2012 and WHO – GMP certified leading global player in Biopharma sector having more than 15 years of operational experience, situated at Hyderabad. We also have offices located in USA. Innovative, ever motivated Research team and uncompromising manufacturing team in providing quality products are our strengths.
Requirement of Manpower for Manufacturing (Vial, Cartridge, PFS & BFS)
Familiar with cGMP guidelines and Quality Systems as per the international regulatory requirements. Experience in Oral Solid Dosage Manufacturing / CVC Packaging. Exposure to the latest manufacturing and packing techniques.
Dossier submission and review of Module 1, 2 and 3. ANDA submission. DCP, MRP, National Filing for various EU countries. Formulation regulatory for solid orals, Topicals, Ophthalmics, Solutions. Experience in management of life cycle and post approval variations. Experience of communication with agencies.