Executive, Regulatory Affairs / Production (Sterile manufacturing)
Job Description
Title: Executive, Regulatory Affairs / Production (Sterile manufacturing)
Company Name: Square Pharmaceuticals Ltd.
Vacancy: Not specific
Job Location: Gazipur (Kaliakair)
Employment Status: Full-time
Educational Requirements:
∎ M. Pharm / B. Pharm (Professional) (From reputed Universities)
Experience Requirements:
∎ At least 2 year(s)
Job Responsibilities:
∎ Job Description for Regulatory Affairs:
∎ Prepare CTD (Common Technical Documents) /ACTD (ASEAN Common Technical Documents) and dossiers for export markets
∎ Provide updated regulatory information to respective concerns and follow up the implementation
∎ Review and prepare technical documents associated with CTD / ACTD preparation
∎ Respond to different queries raised by different regulatory authority associated with dossier evaluation or facility inspection
∎ Prepare Annexure/Recipes and arrange Drug Testing Laboratories (DTL) samples as per requirement
∎ Check the newly developed artwork with annexure for both local & export markets
∎ Maintain liaison with different departments & provide feedback regarding inclusion materials for new products
∎ Job Description for Production (Sterile manufacturing)
∎ Monitor and ensure the manufacturing process as per planning, guidelines & Standard Operating Procedure (SOP) to ensure in-time production
∎ Ensure cGMP compliance in all production activities
∎ Prepare Batch Manufacturing Records (BMR), Batch Packaging Records (BPR) and other documents
∎ Participate in validation activity
∎ Supervise & guide the Operators, Helpers and other Production Workers
Additional Requirements:
∎ Age at most 32 years
∎ Minimum 2 years' relevant experience is mandatory
∎ Candidate must possess excellent planning & execution skills as well as strong quantitative & qualitative analytical skills
Salary: Negotiable
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 17 Nov 2022
Company Information:
∎ 8 Nov 2022
∎ Square Pharmaceuticals Ltd.
Category: Medical/Pharma
