プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Subhra S.に依頼

Bangladesh

SOP writing, Quality Risk Management, Root Cause Analysis and Data Analysis expert.

プロフィール概要

I am working as Quality Assurance (QA) Specialist with over 13 years of experience at Beximco Pharmaceuticals Ltd. (A USFDA approved finished drug product manufacturer) At Beximco Pharmaceuticals Ltd. (US FDA–approved unit), I have managed diverse QA functions including deviation investigation, CAPA implementation, risk assessments, internal audits, change control, and document governance while leading successful inspections from USFDA, MMA (Malta EU GMP), WHO, TGA ((Australia), INVIMA (Colombia), DIGEMID (Peru) and more. 💡 Key Competencies: ✔GMP & EU-GMP Compliance: Deep expertise in 21 CFR Parts 210 & 211, EudraLex Vol. 4, and ICH Q10 frameworks. ✔CAPA & Quality Event Management: Proficient in conducting Root Cause Analysis (RCA) for quality events, resolving identified issues, and mitigating potential recurrence through effective implementation of CAPA. ✔Regulatory Audit Preparedness: Hands-on experience leading global audits and responding to agency queries and observations. ✔EQMS & Documentation: Led MasterControl EQMS, EDMS, and ELMS implementation to modernize and digitize QA workflows. ✔Pharmacovigilance (QA role): Supporting post-market quality systems and compliance with PV-QA interface activities. ✔Quality Risk Management (QRM): Applying ICH Q9 principles to assess, control, and communicate risks in operations. ✔Training & SOP Management: Overseeing development, review, and compliance training on SOPs aligned with regulatory requirements.

専門分野

• ★ Risk Management
• ☆ Data Analysis
• ☆ Data Management
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Gap Analysis

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing

Research User Research

Consulting Healthcare Consulting, Regulatory Consulting

Product Development Product Validation

職務経験

Quality Assurance Specialist

Beximco Pharmaceuticals Ltd.

4月 2012 - 現在

学歴

Master of Pharmacy

University of Rajshahi

1月 2010 - 12月 2010

Bachelor of Pharmacy

University of Rajshahi

1月 2005 - 12月 2009

認定資格

• Certified Quality Improvement Associate

  Drug Administration of Bangladesh

  7月 2018 - 現在