Job Summary
Published On : Apr 25, 2024
No. of Vacancies : 01
Job Type :
Full Time
Job Level :
Experience : 5 to 10 years
Location : Narayanganj (Siddirganj)
Salary Range:
Negotiable
Application Deadline : May 24, 2024
Sr. Executive /Asst. Manager, QA Export Documents
A Reputed Pharmaceuticals Company
No. of Vacancies
01
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)
Experience Requirements
- 5 to 10 years
- The applicants should have experience in the following business area(s):
- Manufacturing (FMCG), Pharmaceutical/Medicine Companies, Group of Companies
Additional Job Requirements
Location
Narayanganj (Siddirganj)
Salary Range
Negotiable
Other Benefits
Provident fund, Gratuity
Salary Review: Yearly
Lunch Facilities: Full Subsidize
Festival Bonus: 2
Job Source
Bdjobs.com.bd Online Job Posting
Application Deadline : May 24, 2024
Company Information
Company Name:
A Reputed Pharmaceuticals Company