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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...tion/Test Planning and Execution
- 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
Portfolio Projects
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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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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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
Show More Show LessVerifications
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Profile Verified
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Phone Verified
Preferred Language
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English - Fluent
Available Timezones
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