Job Description
Title: Sr. Executive /Asst. Manager, QA Export Documents
Company Name: A Reputed Pharmaceutical Company
Vacancy: 1
Location: Narayanganj (Siddirganj)
Experience:
∎ 5 to 10 years
∎ The applicants should have experience in the following business area(s):Manufacturing (FMCG), Pharmaceutical/Medicine Companies, Group of Companies
Published: 2 Jun 2024
Education:
∎ Master of Pharmacy (M.Pharm)
Requirements:
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.
∎ 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:
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)
Company Information:
∎ A Reputed Pharmaceutical Company
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 2 Jul 2024
Category: Medical/Pharma
