Must have handled critical equipment like reactor, centrifuge, blender, sifter, multi-mill, etc. Ensure that the products are manufactured as per the cGMP.
Prepare and execute of Process validation, Hold time study protocol and compilation of Process validation reports. To monitor Equipment Qualification, HVAC and Utility validation schedule as per VMP.
Bharat Parenterals Ltd. is a Gujarat based pharmaceutical company, established in 1992 by Mr. Ramesh Desai, who started the company with a vision of making world class affordable medicines and to take it to the forefront of contract manufacturing units in Gujarat.
Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority, package insert, SmPC, PIL & MSDS preparation
Bachelor or Master degree in Pharmacy with a specialization in Pharmaceutics or Pharmaceutical Technology. Responsible to Organize and Co-ordinate Training Activities, Preparation of documents and Maintenance of training records. Responsible for material code initiation.
B.Pharm or M.Pharm qualification with atleast 20 years of experience and most recently have 3 years of experience in a multiline commercial manufacturing facility.
This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for New Drug Applications across globe. Regulatory activities focus on filing activities/query responses/post approval changes as suggested across globe.