Kritika Hans
SAP S/4 HANA QM | CSV Expert | Regulatory Risk Manager | Quality and Compliance Expert for Manufacturing Equipments | QA Data Test Engineer (GCP) | Data Integrity Expert | GxP systems/equipments Auditor & Reviewer
- Role
- Quality Assurance Lead at Vertex Pharmaceuticals
- Location
- Easton, PA, US
- LinkedIn followers
- 500 followers
About Kritika Hans
My organisations has benefited from over 10+ years of expertise in quality assurance, with a focus on validation, compliance, and regulatory standards. The team has contributed to the development and review of validation packages across computer systems, adhering to GAMP5 principles and FDA guidelines. Efforts have included GxP assessments, 21 CFR Part 11 compliance evaluations, and functional risk analyses using FMEA methodologies, ensuring alignment with global regulatory requirements. I have also contributed in data management by Data Integrity Assessment, Security and Data Handling & Processing in Drug Manufacturing Domain. Fair experience in System Periodic Reviews and Internal Audits.Previous roles involved collaborating with cross-functional teams to enhance quality control processes for medical devices and systems under ISO 13485 and 21 CFR Part 820.30/820.70. A commitment to continuous learning and a results-oriented approach has supported successful regulatory engagements with pharmaceutical clients across the EU and US.
Experience
Quality Assurance Lead
Jun 2023 — Present · Boston, MA, US
Education
Hans Raj Mahila Maha Vidyalaya, Jalandhar
Bachelor of Computer Application, Computer Programming, Specific Applications
2011 — 2014
Swami Vivekananda Subharti University, Meerut
Master of Business Administration - MBA, Operations, Project Management & IT
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