Shalika Misra
Associate Director @ Sandoz | IT Security & Quality Assurance
- Role
- Associate Director at Sandoz
- Location
- New Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Shalika Misra
At Sandoz, my focus is on leading quality assurance and compliance initiatives within IT, leveraging my expertise in digital transformation projects and cloud applications. The role capitalizes on my experience in managing intricate GxP-related IT programs, ensuring meticulous adherence to industry regulations and standards such as GAMP5 and 21 CFR Part 11. Our team\'s commitment to excellence facilitates the successful cutover and hypercare phases of significant projects.Previously, as a Senior Manager at Deloitte, I helmed the validation and qualification sectors for large-scale pharma digital transformation programs, which included cloud migration and IT automation. Proficient with Infor M3 and adept in tools like Remedy and ServiceNow, I have successfully responded to customer RFPs and RFIs, aligning new age digital requirements with robust risk advisory strategies. My leadership in these transformative initiatives is underscored by a dedication to continuous improvement and a strategic vision for technology\'s role in advancing healthcare.
Experience
Associate Director
Nov 2023 — Present · IN
Education
La Martiniere Girls' College
10th & 12th, Commerce
1988 — 2002
Banasthali Vidyapith
Master of Computer Applications (MCA), Computer Science
2002 — 2008
Skills
- Software Development Life Cycle (Sdlc)
- Team Leadership
- 21 Cfr Part 11
- Requirements Analysis
- Change Management
- Computer System Validation
- Pharmaceutical Industry
- Valgenesis
- Service-Now.com
- Business Analysis
- Pharmacovigilance
- Quality Assurance
- Argus Safety
- Quality System
- Document Management
- IT Periodic Reviews
- Documentum
- Testing
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