A Reputed Pharmaceutical Company

Summary

Education

Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm), Master of Science (MSc) in Chemistry

Experience

To prepare registration dossiers of the drug product as per Common Technical Document (CTD), ASEAN Common Technical Document (ACTD), and the General format (country-specific) for the registration of Pharmaceutical Products with the regulatory agencies of different countries.
To review Standard Testing Procedure (STP), Standard Operating Procedure (SOP), Batch Documents, APQR Report, Process validation Protocol & Report, API Drug Master File, Test & Analysis reports of Finished product, Raw Material, and Packing Material for dossier preparation.
To prepare and review module-1 of CTD as per the requirements of foreign regulatory agencies, Quality Overall Summary-Product Dossier (QOS-PD) Word template, and Quality Information Summary-Product Dossier (QIS-PD) format of different foreign regulatory agencies.
To prepare Certificate of Analysis (COA) of Raw Material, Packaging Material & Finished Product for export dossier and during shipment of the specific product.
To provide documents, information and clarification following the Notice of Deficiency (NOD) / Query from the foreign regulatory agencies.
Coordinate and correspond with Quality Control, Production, R&D, International Marketing, Commercial department and different regulatory authorities.

Work at office

Full Time

Narayanganj (Siddirganj)

To apply for this job email your details to admin@chakricircular.com