Job description
Roles and Responsibilities
· Coordination and review the CMC documents from respective departments for compilation of DMF.
· Responsible for preparation of declarations (i.e commitment letters, GMP certificate, TSE/BSE etc.) as per customer requirements.
· Knowledge of Preparation, compilation & review e-CTD Dossiers.
· Preparation of query compliance report for Drug Regulatory Authorities.
DRA- Executive & Manager
Qualification:
B.Pharma
M.Pharma