Designation: Asst Executive DRA
Job Location: Kandivali
Expierence: 4 yrs & Above
Salary: As per industry std.
-Handling filing of ANDA for USFDA.
-Review of formulation related documents like PDR (as per QBD concept), BMR, BPR, stability protocols & Stability Data.
-Handling post approval changes, PAS and supplement filing.
-Handling query responses submission
-Review of Specification, CQA of API, raw material, Packaging material and finished Products.
-Compilation of Documents as per eCTD requirement for CMC section for module 1 to Module 3 and annual updates.
-Co-ordination with documentation department, formulation development, manufacturing location for revision of Specification and standards test procedure.
AmyPvt. Ltd which is an ISO 9001 – 2008 certified company.
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