プロフィール詳細

プロジェクトを作成

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Sohanur R.に依頼

Bangladesh

Pharma Expert | 15+ Yrs in Deviation, QMS & Audit-Ready CAPA | CCS, SOP, and Documents Review | FDA, EU Annex-1:2022 |

プロフィール概要

Pharmaceutical quality and compliance specialist with over 15 years of experience in sterile manufacturing environments. Holds a Master’s degree in Pharmacy and is a licensed pharmacist, with advanced training in GMP systems and regulatory compliance. Expertise includes: - Deviation & CAPA Strategy: Skilled in reviewing and closing deviations, formulating audit-ready CAPAs, and resolving inspection findings - QMS Documentation: Technical review of SOPs, Change Controls, Annual Product Quality Reviews (PQR), and supplier qualification records - Media Fill Oversight: Support for planning, execution, and deviation handling in aseptic simulations - Audit Readiness: Gap assessments and strategic input to strengthen inspection outcomes and regulatory alignment Contamination Control Strategy (CCS): Experienced in CCS handling as per EU Annex-1:2022, including risk-based contamination control planning, integration with QMS, and alignment with aseptic processing requirements. Work is grounded in global regulatory standards including FDA, EU GMP, WHO, and ICH. Well-versed in the latest Annex-1 updates and their impact on aseptic operations and contamination control. Recent and ongoing projects include: - Reviewing CAPA plans following regulatory inspections - Assessing deviation documentation for closure and compliance - Supporting teams in aligning documentation with evolving regulatory expectations - Advising on QMS improvements, supplier evaluation, and PQR reporting Committed to precision, confidentiality, and helping organizations meet the highest standards of pharmaceutical quality. To verify my track record and review successful project outcomes, please visit my professional consulting profile, which includes client testimonials and sample deliverables: https://www.fiverr.com/s/akqQW7A

専門分野

• ☆ Biostatistics
• ☆ Chemical Engineering
• ☆ Chemical Manufacturing
• ☆ Industrial Engineering
• ☆ Manufacturing
• ☆ Manufacturing Facility Design
• ☆ Continuous Process Manufacturing
• ☆ Lean Manufacturing
• ☆ Manufacturing Optimization
• ☆ Automation
• ☆ Manufacturing Automation
• ☆ Data Analysis
• ☆ Data Processing
• ☆ Statistics
• ☆ Food Microbiology
• ☆ Food Processing
• ☆ Food & Beverage Manufacturing
• ☆ Risk Assessment & Actuarial Science
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Discovery
• ☆ Drug Design
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Vaccine Development
• ☆ Pharmaceutical Manufacturing
• ☆ Extractable & Leachable Testing
• ☆ Pharmaceutical Process Development
• ☆ Bioprocess Development
• ☆ Small Molecule Manufacturing
• ☆ Biologic & Biosimilar Manufacturing
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Health Technology Assessment
• ☆ E-Health & Telemedicine
• ☆ Healthcare Administration & Management
• ☆ Managed Healthcare
• ☆ Healthcare Quality Improvement
• ☆ Rural Health
• ☆ School Health Services
• ☆ Pharmaceutical Management
• ☆ Drug Delivery Technologies
• ☆ Liposomes
• ☆ Pharmaceutical Technology
• ☆ Healthcare Reimbursement
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ Project Management
• ☆ Risk Management
• ☆ Six Sigma
• ☆ Management Consulting

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, General Proofreading & Editing, Translation

Research Market Research, User Research, Scientific and Technical Research, Secondary Data Collection

Consulting Business Strategy Consulting, Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Data Visualization, Data Mining, Data Processing, Data Insights

Product Development Formulation, Recipe Development, Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Product Launch Support, Packaging Design, Prototyping, Reverse Engineering, Device Fabrication

職務経験

Independent Pharmaceutical QA & Compliance Consultant

Consultant- Self-Employed (based on over 15 yrs experience in Pharma industry)

1月 2023 - 現在

学歴

Master in Pharmacy

State University of Bangladesh

1月 2010 - 4月 2011

認定資格

• Pharmacist registration certificate

  Pharmacy Council of Bangladesh

  1月 2010 - 現在