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:
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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
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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
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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.