Name variants:
Shilpi Guliani
Last updated Jun 07, 2024
Contact Information
Workplace
Associate Director, It Quality Engineering
San Mateo, CA
Industry
Biotechnology, Mfg Biological Products, Pediatrician, Internist, Pharmaceutical Preparation Manufacturing, Biological Product (except Diagnostic) Manufacturing
Colleagues
Work History
Associate Director, It Quality Engineering
333 Lakeside Dr, Foster City, CA 94404
from Jul 2018
Associate Director of Information Technology Quality
251 Ballardvale St, Wilmington, MA 01887
Apr 2018 — Jul 2018
Associate Director of Information Technology Quality
54943 north Main St, Mattawan, MI 49071
Leading and managing IT Quality Management System (QMS), Change Management Program and providing governance for over 100 IT Vendors
Leading and managing Validation and test teams to provid...
Sep 2016 — Mar 2018
Advanced Quality Engineer - Staff
2825 Airview Blvd, Kalamazoo, MI 49002
Leading Quality for all software platforms at Stryker, Medical resulting in standardization of technology blocks
Leading Computer System Validation for all GxP systems at Stryker Medical r...
Dec 2013 — Mar 2016
Validation Manager, Computer System Validation
Leading delivery of IT solutions including computer system validation, solution implementation, user training and support resulting in highest customer satisfaction and team engagement in t...
Jul 2012 — Jul 2013
Manager, Computer System Validation
Creating Validation strategies for global systems based upon risk and complexity
Lead data integrity initiatives including platforms and solutions for Ranbaxy as part of consent decree wit...
May 2011 — Jun 2012
Software Engineer
2825 Airview Blvd, Kalamazoo, MI 49002
Developed Design Controls and SDLC as per IEC 62304
Developed Quality Management System as per ISO 13485
Developed Roadmap for 21 CFR Part 11 compliance
Performed gap analysis for US FDA...
Jan 2008 — Jul 2009
Education
1997 — 2000
Occupations
Executive
Deputy Director
Scientist
Biotechnology Professional
Information Technology Director
Supporting Member
Deputy Manager
Chief Executive
Biologist
Biological Scientist
IT Manager
Team Member
Skills
Computer System Validation
21 Cfr Part 11
Gamp
Iso 13485
Quality Assurance
Gmp
Validation
Gxp
Quality Control
Sop
Iec 62304
Management
Fda
Testing
Change Control
U.s. Food and Drug Administration
Sdlc
User Acceptance Testing
R&D
Medical Devices
Annex 11
Iso 14971
Software Development Lifecycle
FAQs about Shilpi Guliani
What is the profession of Shilpi Guliani?
This professional's job is Associate Director, It Quality Engineering
What are the profession of The expert?
These person's professions are Executive and Deputy Director
Where does Shilpi Guliani live?
They currently lives in Kalamazoo, Michigan.
What is the expert's email?
Shilpi's email is sh**@stryker.com.
How many companies did Shilpi Guliani work at?
The professional worked at nine jobs.
What education does Shilpi Guliani have?
Shilpi studied at the Cal State East Bay - College of Business & Economics from 2003 to 2005.
What are the certifications of Shilpi Guliani?
Shilpi received the following certifications: Lead Auditor For Iso 13485 and Oriel Stat A Matrix.
What languages does Shilpi Guliani speak?
Shilpi Guliani speaks English and Hindi.