Executive/ Sr. Executive-Quality Assurance(Dossier)

Job Description

Title: Executive/ Sr. Executive-Quality Assurance(Dossier)

Company Name: A Reputed Pharmaceuticals Company

Vacancy: --

Location: Narayanganj

Maximum Salary: Negotiable

Experience:
∎ 1 to 5 years

Published: 2 Oct 2024

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

Requirements:

Responsibilities & Context:
∎ To prepare and check 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.
∎ To check the Certificate of Analysis (COA) of Finished Products, Raw Materials and Packaging Materials of Exporting Products.
∎ To check 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.
∎ To provide documents, information and clarification following the Notice of Deficiency (NOD) / Query from the Foreign Regulatory Authority.
∎ 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.

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: 1 Nov 2024

Category: Others