Assistant Manager - Quality Assurance (Dossier)

Job Description

Title: Assistant Manager - Quality Assurance (Dossier)

Company Name: A Reputed Pharmaceuticals Company

Vacancy: 1

Location: Narayanganj

Maximum Salary: Negotiable

Experience:
∎ 6 to 12 years
∎ The applicants should have experience in the following business area(s):Manufacturing (FMCG), Hospital, Pharmaceutical/Medicine Companies, Group of Companies

Published: 17 Dec 2024

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

Requirements:

Responsibilities & Context:
∎ 1.To prepare/check 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.
∎ 2.To provide documents, information, and clarification following the notice of deficiency (NOD) / query from the foreign regulatory authority.
∎ 3.To check the certificate of analysis (COA) of finished products, raw materials, and packaging materials of exporting products.
∎ 4.To check certificate of analysis, standard testing procedures of raw materials, packaging materials & finished products, batch documents, product annexures, APQR reports, process validation protocol & reports, QC analytical documents, and records of finished products, raw materials, packaging materials, and API drug master file for dossier preparation.
∎ 5.To prepare & check 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.
∎ 6.Coordinate and correspond with quality control, production, R&D, engineering, international marketing, commercial department and different regulatory authorities.
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Skills & Expertise:

Workplace:
∎ Work at office

Employment Status: Full Time

Job Location: Narayanganj

Company Information:
∎ A Reputed Pharmaceuticals Company

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

Application Deadline: 16 Jan 2025

Category: Others