プロフィール詳細

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NAVEEN A.に依頼

India

Pharmaceutical & Medical device professional

プロフィール概要

Bio-pharma & Medical Device Quality Consultant having a good blend of Manufacturing, Technology & Business with in-depth understanding of Life Science industry. More than 9 years of experience in Medical device design and development, Process Engineering, Manufacturing, Risk Management, Quality Assurance, Validation and pharma compliance (GxP and CSV). Engaged with clients to deliver process and technology consulting work in Pharmaceutical & Medical Device Industry. I have led and delivered assignments around technology transformation, business model redesign, Quality Management system, Audit Remediation & Quality Compliance. Expertise: - Process Design, Process engineering, Technology Transfer, Process Validation, Media Fills, Sterile manufacturing, Manpower management. - QMS- Deviation management, Root cause investigation, CAPA, Change management. - Medical device, Design Validation, DHF/DMR/DHR. - EUMDR/IVDR. - 510(k) - Computer system Validation & Quality Compliance. - SAP-ERP, LIMS, DCS, PLC, Argus, Reporting,BMS,Valgenesis etc - Data integrity, Access controls, ISMS, GDPR. - ISO 13485, ISO 14971, IEC xxxxxxxxx CFR Part 11, 21 CFR Part xxxxxxxxxxxxxxx - Process scale-up, facility design as per cGMP norms. - Formulation, Filling(Blow Fill seal technology) and Packaging development. - Concept and basic engineering of biotech plants in terms of layout planning (based on process flow), generation of P&IDs, design calculations (including utility estimates), equipment sizing etc. - URS preparation and Bioprocess equipment design - Coordination within internal (cross functional teams) and external (partners, clients, vendors) stakeholders - Commissioning and Qualification inclusive of FAT, SAT, IQ and OQ - Equipment budgeting ; cost monitoring and procurement. Skills: Manufacturing,MSAT, Technology Transfer, Process design, Process Engineering, Equipment Validation,QA, QMS, Quality System implementation, Computer Systems Validation, GxP, GAMP 5, IT Security, Change management, Process Validation, Cleaning Validation, EUMDR.

専門分野

• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Pharmaceutical Management
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Medical Device Regulatory Writing

サービス

• Writing
• Consulting
• Product Development

Writing Technical Writing

Consulting Scientific and Technical Consulting

Product Development Product Validation

職務経験

Manager

Medtronic

7月 2017 - 現在

Manager

Biocon

2009 - 2017

学歴

Masters in Biotechnology

Indian Institute of Information Technology, Guwahati

6月 2007 - 7月 2009

認定資格

• ISO 13485

  bsi

  6月 2019 - 現在