Associate Scientist, R&D / Executive, Regulatory Affairs (Global)
Job Description
Title: Associate Scientist, R&D / Executive, Regulatory Affairs (Global)
Company Name: Square Pharmaceuticals Ltd.
Vacancy: Not specific
Job Location: Gazipur (Kaliakair)
Employment Status: Full-time
Educational Requirements:
∎ M.Pharm / B.Pharm / M.Sc in Chemistry or Applied Chemistry or Bio-Chemistry & Molecular Biology (from public or reputed private University)
Experience Requirements:
∎ 2 to 3 year(s)
Job Responsibilities:
∎ For Research & Development
∎ Conduct formulation activities for new & existing products and pre-formulation study for method development
∎ Perform analytical method development for both compendia & non-compendia method
∎ Ensure the trouble-shooting activities by maintaining compliance with quality
∎ Raise Document initiating form Change Control Report, Change Document Report, Handling of Deviation and perform risk assessment as per requirement
∎ Prepare Process Optimization (PO), Process Validation (PV) documents like protocol, batch documents etc. and conduct the PO and PV Batches as per procedural requirement
∎ Analysis of stability sample for new products as per schedule
∎ Conduct analytical method validation and verification for new products
∎ Conduct operation of HPLC, GC, UV-VIS spectrophotometer & Atomic spectrophotometer
∎ Compile analytical documentation with maintaining GDP
∎ Perform cleaning validation activities as per regulatory requirements
∎ 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
Additional Requirements:
∎ Age at most 32 years
∎ 2-3 years' relevant experience is mandatory
∎ Good interpersonal and communication skills
∎ Candidate must possess excellent planning & execution skills as well as strong quantitative & qualitative analytical skills
∎ Well conversant with MS Office
Salary: Negotiable
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 25 Sep 2021
Company Information:
∎ 15 Sep 2021
∎ Square Pharmaceuticals Ltd.
Category: Medical/Pharma
Source: bdjobs.com
Deadline Expired on 25th Sep 2021
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