Assessing Change request assigned to ensure regulatory assessment along with strategy and documents required for any regulatory submissions are shared with stakeholder in a timely fashion.
Experience in handling equipment like Reactor, Centrifuge, ANFD, Multimill, Micronisation, Sparkler filters, Technology Transfer for scale up at Pilot Plant. Handled finished goods store, Dispatch, Export, Domestic Knowledge of E-Way Bill, customs, GST.
Regulated markets and currently working as a shift incharge. Experience in compression, granulation and should possess expertise in Quality Management System (QMS) production.
M.Pharma, M.Sc. in Life Sciences, MBA ; Organizing promotional programs & participation in exhibitions for greater brand visibility including fixing meetings around conferences. Meet, exceed the business closure targets from assigned territory.
Support the implementation of new/revised data systems, technologies, and methods to improve Clario services or support Operation expansion. Participating in systems implementation teams.
Sterile manufacturing Suspension/emulsion /PFS / BFS as well as SKID operation. Should have experience in Aseptic process, complex manufacturing, Exposure to CIP/ SIP SKID, QMS.
Compile registration dossiers for submission to various health authorities like – USA, Canada, Europe, Australia and Israel. Prepare responses to deficiency letters received from various agencies.
Responsible for smoother operation of NMR instruments, shift planning and execution to achieve benchmark productivity month on month basis. Responsible for planning, prioritizing and executing work responsibilities in order to meet deadlines.
For all the positions, it is essential for candidates to have exposure in Injectable Sterile plant and regulatory requirements of documentation as per cGMP/GLP.