বিবরণ : Sr. Executive /Asst. Manager, QA Export Documents - For A Reputed Pharmaceuticals Company (Job ID :1247173). সংস্থা : Bdjobs.com. অবস্থান : Narayanganj District

A Reputed Pharmaceuticals Company is looking for Sr. Executive /Asst. Manager, QA Export

Job Description / Responsibility

To prepare new document format for dossier as per requirement of Foreign Regulatory Authority.
To prepare new document format for clarification documents [NOD (Notice of Deficiency) / Query documents / Clarification Documents] as per requirement of Foreign Regulatory Authority.
To check prepared documents (Part / Section) for Common Technical Document (CTD), ASEAN Common Technical Document (ACTD), eCTD, National Format (NF) Dossier/ General Format Dossier.
To check Standard Testing Procedure (STP) of Finished Product, Raw Material & Packaging Material; Finished Product Process Validation protocol & report; Finished Product Stability Study Protocol & Data; Finished Product QC test report to prepare Certificate of Analysis (COA) for export shipment & export documentation Purpose.
To prepare & check Drug Registration Application Form, Quality Overall Summary-Product Dossier (QOS-PD) Word template, Quality Information Summary-Product Dossier (QIS-PD) format as per different foreign regulatory agency.

Educational Requirements

Master of Pharmacy (M.Pharm)
Skills Required: Regulatory

Experience Requirements

5 to 10 year(s)
The applicants should have experience in the following business area(s): Manufacturing (FMCG), Pharmaceutical/Medicine Companies, Group of Companies

Job Location

Narayanganj (Siddirganj)