Assistant Manager, QA (Dossier)

Job Description

Title: Assistant Manager, QA (Dossier)

Company Name: A Reputed Pharmaceuticals Company

Vacancy: --

Location: Anywhere in Bangladesh

Maximum Salary: Tk. 70000 (Monthly)

Experience:
∎ At least 6 years
∎ The applicants should have experience in the following business area(s):Manufacturing (FMCG), Hospital, Pharmaceutical/Medicine Companies, Group of Companies

Published: 7 Oct 2024

Education:
∎ Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm)

Requirements:

Responsibilities & Context:
∎ To prepare and review the Dossier of Product as per the Common Technical Document (CTD), ASEAN Common Technical Document (ACTD) and General (country-specific) format for the registration of Pharmaceutical Products for the overseas market.
∎ Coordinate and correspond with Quality Control, Production, R&D, Maintenance, International Marketing, Commercial department and different regulatory authorities.
∎ To provide documents, information and clarification following the Notice of Deficiency (NOD) / Query from the Foreign Regulatory Authority.
∎ To prepare and review module-1 of CTD as per the Registration Application Form, Quality Overall Summary-Product Dossier (QOS-PD) Word template, and Quality Information Summary-Product Dossier (QIS-PD) format of different foreign regulatory agencies.
∎ Conduct coordination meetings between Quality Assurance and the International Marketing Department.

Workplace:
∎ Work at office

Employment Status: Full Time

Job Location: Anywhere in Bangladesh

Company Information:
∎ A Reputed Pharmaceuticals Company

Read Before Apply: Please apply only who are fulfilling all the requirements of this job

Application Deadline: 6 Nov 2024

Category: Others