About Me
- 16.5 Years experience with deep knowledge in Computer System/Medical device and Pharmaceutical Validation, Validation/Test Strategy, Validation/Test Planning and Execution
- Core Competencies in Quality Management, Computer System...
- Core Competencies in Quality Management, Computer System Validation, Medical Device Validation, Risk based validation, FDA, GAMP5 and Pharma Regulations, 21CFR P11, 820, ISO 9001 Lead Auditor, CAPA, Change Management and Lean Six Sigma principles
- Domain and Regulatory experience includes in the area of - Bioinformatics, Genomic, Proteomics, 21CFR Part 11/820, ISO 13485/14971/9001, IEC62304 US FDA Guidelines, MDD/MDR, GAMP5, cGMP, eCTD, SPL and Computer systems validations (CSV), LIMS, QMS, SOP
- Certification in PRINCE2, Lean Six Sigma, Scrum Master/SAFe 4.0, ITIL, COBIT and ISO 9001
Skills
Software Engineering
Web Development
Software Testing
Others
Development Tools
Database
Portfolio Projects
Company
Pharmaco vigilance
Role
Project Manager (Team Lead)
Description
Building a product for Pharma/Health Industry. This product is being designed and architected from scratch and would heavily leverage the latest in AI/ML. Managing and Leading the E2E Testing, Validation and Compliance activities for CORA PVAI. Providing Testing and Validation strategy and Planning. Preparation of QA Strategy, Managing Multiple Stakeholders Onsite and Off Site. Managing End-to-End Product Development, Validation, and testing/release activity in adherence to FDA/EU Regulatory guidelines
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Agile Software Development AWS J2EETools
JIRA Visual Studio (Win)Company
Change and Configuration Management, Trackwise, Excellent Care, SAP MES and Valgenesis
Role
Project Manager (Team Lead)
Description
Managing and Leading the E2E Testing and Validation activities for Large Programs. Providing Testing and Validation strategy and Planning. Preparation of QA Strategy, Managing Multiple Stakeholders Onsite and Off Site. Managing End-to-End Product Development, Validation, and testing/release activity in adherence to FDA/EU Regulatory guidelines
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J2EETools
JIRACompany
ION Torrent Suite – ION Reporter, Torrent Suite and Ampliseq (NGS-Next Generation Sequencing Tool)
Role
Project Manager (Team Lead)
Description
Managing and Leading the Quality, Testing and Validation activities of Diagnostic product. Preparation of QA Strategy, Managing Multiple team in Onsite and Off Site. Managing End-to-End Product Development and release activity.
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J2EETools
JIRACompany
MES, PLM, LES, LIMS, SAP and Trackwise
Role
Analysts (Non programmer role)
Description
Managing and Leading the Validation and Regulatory activities of IT Transformation project for Manufacturing, Laboratory and Research Department. Preparation and review of Validation Deliverables such as Impact Assessment, VP, IQ, OQ, PQ and VSR, supporting Deviation Management, CAPA, Periodic Review and Change controls, Supporting Internal audit, Client Audit and External Audit
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Java (All Versions)Tools
JIRA