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Kaizad
kaizad20@yahoo.com
281-865-4341
Sr. Manager/ Associate Director - Enterprise Architecture Operat
17 years experience W2
0
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Average rating
4
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Summary

  • Systems Implementation
  • cGMP/GAMP
  • System Testing
  • SOX, ISO 27001, FDA 21 CFR Part 11
  • Process optimization
  • SDLC (Waterfall, Agile)
  • Release Management
  • SAFe 4 Practitioner & Scrum Master Certified
  • Mentoring & Training
  • Program Management
  • Change Management
  • Azure DevOps
  • Validation (IQ, OQ, PQ)
  • LIMS Lifecycle (LabWare V6, V7, V8, LEM)

Experience
IT Program & Release Manager/Scrum Master SDLC
Professional/Consulting Services
Jan 2015 - present
  • Empower teams to self-organize and grow cross-functionally
  • Manage release cycles & coordinate releases with Oracle & other teams
  • Established a standard SDLC & release process for the team to fit Agile methodology
  • Coach teams on Scrum framework and best practices including change management
  • Manage offshore development team dedicated to defect triage
  • Facilitate Scrum ceremonies (daily stand-ups, retrospective, sprint planning, backlog grooming)
  • Server Governance - 18 Citrix, 12 background, 10 web. Environments : Dev, QA, PROD, TRN
  • Produce Deployment Run Books and Implementation Plans.
  • Lead CAB meetings to discuss release scope and/or roadblocks.
  • Manage risks and resolve issues that affect release scope, schedule and quality.
  • Collaborate globally with all participants in software development projects.
  • Build the IT Release Calendar by working closely with IT managers across all business units.
  • Conduct Release Readiness reviews, Milestone Reviews and Business Go/ No-Go reviews.
  • Manage post implementation support and report status.
  • Collect release feedback from stakeholders for continuous improvement.
Agile Methodology Change Management Scrum SDLC Project Management Quality Assurance Stakeholder Engagement Scrum Master
Remove Skill
Information Technology
Aug 2007 - Mar 2010
Area Recruited to provide high level analysis, enhancement, and management of business critical regulated Laboratory Information Management System (LIMS), supporting enterprise-wide manufacturing, testing and production operations. Critical liaison and 'go-to' resource for high-risk LIMS projects and business implementations.
• Managed personnel and projects related to validating automated systems using GAMP - Good Automated Manufacturing Practice recommended SDLC 'V' model. ? Specifications - User requirements, functional specifications, hardware & software design, module specifications ? Systems testing against specifications - IQ, OQ, PQ documentation
• Monitored & Controlled Quality Management, Change Control and Risk Management process.
• Utilized Trackwise (quality management system) for CAPA - corrective and preventive action.
• Extensive experience with 21 CFR Part 11 Compliance (Electronic Records, Electronic Signatures, Validation, Time Stamp, Audit Trail)
• Analyzed and optimized system performance, ensuring system stability, scalability, and integration of quality data architectures.
• Credited with automating Out of Specification (OOS) Investigation process, driving immediate and measurable improvements in productivity and efficiency while achieving compliance with FDA regulations and audits.
• Drove on time delivery of Instrument Interfacing project focused on interfacing laboratory instruments with LIMS data system. Enabled automatic transfer of analytical results into data system, triggering significant cost savings through reduction in manpower while increasing accuracy and efficiency.
• Planned and coordinated initiative to develop and implement background schedulers for environmental monitoring, resulting in automation of numerous processes from sample logging to result entry and test assignment.
No skills were added
Remove Skill
Business Systems Analyst - Vaccines Research
Information Technology
Aug 2004 - Aug 2007
(now Pfizer) Pearl River, NYC Performed in-depth analysis of business systems and processes to support and drive the integration of vital systems and process improvements for company's Vaccine Research Department. Executed validation protocols, quality system configuration, change control, testing, and support.
• Consistently met project milestones while managing strict time line constraints.
• Maintained good documentation practice while validating quality system (IQ, OQ, PQ)
• Tracked change control documents that required review and approval
• Performed post implementation review by measuring the benefits and objectives
• Monitored & Controlled user acceptance testing
• Create appropriate training materials and plan out training sessions
• Designed business flow diagrams using Visio
• Managed System Migration and integration to Lab instruments
• Planned risk analysis prior to installing patches by categorizing them as low/ med/high & regression test cases from prior validation.
BSA Process Improvement System Analysis
Remove Skill
Edit Skills
Non-cloudteam Skill
Education
Finance, General
Philadelphia University 2007
Business Administration
Philadelphia University
Certifications
using Scrum framework
CSM
Certified Scrum Master with expertise in managing software
development projects from various industries including global
Pharmaceutical (Vaccines Research), Biotech (Manufacturing
Testing, QA), Oil & Gas and Safety Science Certification industry
Results-Driven leader with proven success in cost-controlled
program management
change management, process governance
deployment planning, SDLC (Waterfall, Scrum) Azure DevOps
(VSTS) and release management
Knowledge of compliance activities in a FDA regulated
Pharmaceutical and Biotech industry for Quality Systems within a
GMP environment (cGxP GAMP)
Skills
Scrum Master
2021
5
Agile Methodology
2021
4
Change Management
2021
4
Project Management
2021
4
Quality Assurance
2021
4
Scrum
2021
4
SDLC
2021
4
Stakeholder Engagement
2021
4
BSA
2007
3
Process Improvement
2007
3
System Analysis
2007
3
Program Management
0
1
Release Management
0
1
Waterfall
0
1