Executive, Regulatory Affairs / Executive, Quality Assurance

Job Description

Title: Executive, Regulatory Affairs / Executive, Quality Assurance

Company Name: Square Pharmaceuticals Ltd.

Vacancy: Not specific

Job Location: Gazipur (Kaliakair)

Employment Status: Full-time

Educational Requirements:
∎ Minimum B. Pharm

Experience Requirements:
∎ At least 2 year(s)

Job Responsibilities:
∎ For Regulatory Affairs:
∎ Prepare CTD /ACTD 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
∎ For Quality Assurance:
∎ Monitor dispensing of raw materials as well as manufacturing & packaging processes in compliance with GMP
∎ Perform IPC, BMR-BPR checking, change control activities and batch release activities
∎ Prepare and control of SOPs and ensure QMS related documentation
∎ Handle the Market Compliant, Deviation, QIR, CAPA, NCR & rejections
∎ Handle the Batch document & Retention Sample and ensure proper investigation of quality incidents
∎ Perform Training Needs Assessments to prepare & conduct training programs of employees

Additional Requirements:
∎ Age at most 32 years
∎ Minimum 2 years' relevant experience is preferable
∎ Candidate must possess excellent planning & execution skills as well as strong quantitative & qualitative analytical skills

Salary:
∎ Negotiable
∎ Attractive remuneration package will be offered

Job Source: Bdjobs.com Online Job Posting.

Application Deadline: 16 Jul 2023

Company Information:
∎ 6 Jul 2023
∎ Square Pharmaceuticals Ltd.
∎ Business : Square Pharmaceuticals Limited, the flagship company of Square group, is holding the 1st position in the pharmaceutical industry among all national and multinational companies of Bangladesh since 1985 and is now on its way to become a high performance global player.

Category: Medical/Pharma

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