Rangs Pharmaceuticals Ltd.

Executive/Sr. Executive, Regulatory Compliance

General Info
  • Published on: Apr 29, 2024
  • Deadline: May 15, 2024
  • Source: Bdjobs.com
Job Details
  • Job Nature: Full-Time
  • Job Location: Gazipur (Gazipur Sadar)
  • Salary:
  • Job Description:
    • To prepare and check Pharmaceutical dossiers like CTD/ACTD.
    • To perform and check Analytical Method Development & Validation.
    • To perform a Stability Study.
    • To prepare and check Clarification/Query/NOD (Notice of Deficiency) documents and site transfer documents, additional documents i.e. Standard Operating Procedure (SOP), Additional documents of drug substance (Active and Excipients) as per foreign regulatory authority.
    • To check STP (Standard Testing Procedure) of Raw Material, Packaging Material & Finished Product, documents of Process Validation Protocol & Report for export documentation purposes.
    • To Prepare & check shipment/sample Certificate of Analysis (COA) of Finished Products, Raw Materials and Packaging Materials for export products.
    • To check Packaging Material Proofread and Standard (Text and Design of Packaging materials) for export products of different countries.
    • To review Batch Documents, Annual Product Review Report (APQR) to assess product quality, Annexure, Working Standard / Reference Standard documents, Active Pharmaceutical Ingredient Drug Master File (API-DMF), British Pharmacopoeia, United States Pharmacopeia & other regulatory guidelines for Product registration purpose.
    • To monitor export packing operations for shipment in different countries.
    • Well conversant in English. Maintain communication with foreigners as need through IMD.
    • Highly proficient in computer and software-based knowledge
Job Requirements
  • Age Specification: At most 33 years
  • Educational Requirements:
    • Bachelor of Pharmacy (B.Pharm)
    • Bachelor of Science (BSc) in Chemistry
    • Bachelor of Science (BSc) in Biochemistry
    • Bachelor of Science (BSc) in Applied Chemistry
  • Experience Requirements:
    • 3 to 5 years
    • The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
Apply Procedure
  • Apply Instructions: Only shortlisted candidates will be called for interview. We offer a career, not a job. We are an equal opportunity employer.