Executive/Sr. Executive, Regulatory Compliance
Job Description
Title: Executive/Sr. Executive, Regulatory Compliance
Company Name: Rangs Pharmaceuticals Ltd.
Vacancy: --
Age: at most 33 years
Location: Gazipur (Gazipur Sadar)
Salary: Negotiable
Experience:
∎ 3 to 5 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies
Published: 29 Apr 2024
Education:
∎ Bachelor of Pharmacy (B.Pharm)
∎ Bachelor of Science (BSc) in Chemistry
∎ Bachelor of Science (BSc) in Biochemistry
∎ Bachelor of Science (BSc) in Applied Chemistry
Requirements:
Additional Requirements:
∎ Age at most 33 years
Responsibilities & Context:
∎ 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
Employment Status: Full Time
Job Location: Gazipur (Gazipur Sadar)
Company Information:
∎ Rangs Pharmaceuticals Ltd.
∎ Rangs Bhaban, 117/A, Level-5, Bijoy Sharani, Old Airport Road, Tejgaon, Dhaka-1215..
Address::
∎ Rangs Bhaban, 117/A, Level-5, Bijoy Sharani, Old Airport Road, Tejgaon, Dhaka-1215..
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 15 May 2024
Category: Medical/Pharma
Source: bdjobs.com
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