A Reputed Pharmaceutical Company
A Reputed Pharmaceutical Company
A Reputed Pharmaceutical Company
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Summary
- Vacancy: 1
- Location: Narayanganj (Siddirganj)
- Experience: 5 to 10 years
- Published: 2 Jun 2024
Requirements
Education
- Master of Pharmacy (M.Pharm)
Experience
- 5 to 10 years
- The applicants should have experience in the following business area(s):
Manufacturing (FMCG), Pharmaceutical/Medicine Companies, Group of Companies
Responsibilities & Context
- 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.
Skills & Expertise
Regulatory
Compensation & Other Benefits
- Provident fund, Gratuity
- Salary Review: Yearly
- Lunch Facilities: Full Subsidize
- Festival Bonus: 2
Workplace
Work at office
Employment Status
Full Time
Job Location
Narayanganj (Siddirganj)