Md Shahnawaz Khan
GxP Quality & Compliance Lead
Bengaluru
Summary
IT Quality & Compliance Senior Specialist with 8+ years of experience driving GxP, ISO 9001, ISO 27001, CSV/A, and SDLC governance across Life Sciences. Demonstrated expertise in risk-based audits, compliance automation, and QMS/ISMS maturity, supporting large-scale Agile and shared services areas.
Overview
9
9
years of professional experience
Work History
IT Compliance Specialist III
Thermo Fisher Scientific
03.2025 - Current
- Lead governance and continuous improvement of SDLC frameworks aligned with ISO 9001:2015, ISO 27001, GxP, and corporate standards across Agile and shared services teams.
- Designed and implemented Power Automate workflows to automate audit communications, reducing manual effort by approximately 70%, and supporting over 50 teams by auto-triggering audit invitations and audit report distribution.
- Transitioned the audit program from a fixed, half-yearly audit cycle to a risk-based audit model, improving audit effectiveness, focusing on high-risk areas, and optimizing audit coverage.
- Own and administer QMS and ISMS, including SOPs, work instructions, tool procedures, and compliance controls, to ensure continuous audit readiness.
- Plan, execute, and report internal audits; drive CAPAs, and track findings to closure in collaboration with engineering and leadership teams.
- Partner with Agile and shared services teams to embed compliance into Agile delivery, while improving quality maturity and delivery velocity.
- Evaluated existing policies regularly, identifying areas for improvement and recommending revisions as needed.
- Act as an SME and mentor for ISO, GxP, SDLC governance, and compliance best practices across global teams.
- Reduced instances of non-compliance through meticulous monitoring of internal controls, and periodic checks.
- Played an instrumental role in preparing the organization for successful completion of ISO 9001:2015 and ISO 27001:2022 certification without major findings levied against the company.
Manager, Life Sciences Consulting
Ernst & Young (EY)
02.2020 - 03.2025
- Led end-to-end validation and compliance engagements for global life sciences and pharmaceutical clients, covering GxP systems such as QRM, VLMS, PLM, CDMS, and internally developed applications.
- Owned engagement delivery and quality, defining validation strategies, risk-based validation approaches, and release strategies aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9, and client standards.
- Provided managerial oversight for authoring, review, and approval of validation deliverables, including Validation Plans, IQ/OQ protocols, RTMs, test scripts, and Validation Summary Reports.
- Acted as the IT Quality Unit representative, reviewing and approving validation deliverables, periodic reviews, deviations, and CAPAs to ensure regulatory compliance and audit readiness.
- Facilitated and chaired IT Change Control review boards, assessing GxP impact, data integrity risks, and regulatory implications of system changes.
- Led data integrity, IT controls, and risk assessments, identifying compliance gaps, and defining mitigation plans in collaboration with QA, IT, vendors, and business stakeholders.
- Managed multiple parallel engagements, ensuring on-time delivery, stakeholder alignment, and adherence to EY quality and risk management policies.
- Mentored and managed teams of up to 10 consultants, providing technical guidance, performance feedback, and capability development across validation and compliance domains.
- Drove continuous improvement initiatives, including SOP development, process standardization, and enhancement of validation and compliance operating models.
- Curated and delivered IT quality and compliance training for internal teams and client stakeholders.
- Supported business development and go-to-market initiatives, contributing to solution development, client proposals, and thought leadership in Life Sciences compliance and validation.
Validation & Compliance Analyst – Life Sciences
Accenture Solutions Pvt Ltd
07.2017 - 02.2020
- Supported system implementation, validation, and change control for EU-based life sciences and pharmaceutical clients.
- Reviewed and approved IQ/OQ test scripts, validation plans, protocols, RTMs, and summary reports.
- Authored validation plans, change control plans, and summary reports in regulated environments.
- Reviewed requirements and design documents to ensure traceability and regulatory alignment.
- Supported validation of internally developed applications in Agile delivery models.
- Participated in defect triage, tracked issues to closure, and ensured compliance with quality processes.
- Ensured training compliance and coordinated tasks across cross-functional stakeholders.
- Conducted regular reviews of company procedures for alignment with regulatory requirements and industry best practices.
Education
Bachelor of Engineering - Electrical And Electronics Engineering
B. M. S. College of Engineering
Bengaluru05-2017
Higher Secondary / Pre-University / 12th Grade -
Al-Ameen PU College
Bengaluru03-2013
High School Diploma -
St. Joseph's Convent High School
Jharkhand03-2011
Skills
Computer System Validation (CSV) & GxP Compliance
Certifications
- Project Management Professional (PMP) – PMI
- Certified ScrumMaster (CSM) – Scrum Alliance
- Scrum Foundation Professional Certificate
- ISO 9001:2015 Lead Auditor
- ISO 27001:2022 ISMS Lead Auditor
- ITIL® 4 Foundation
Timeline
IT Compliance Specialist III
Thermo Fisher Scientific
03.2025 - Current
Manager, Life Sciences Consulting
Ernst & Young (EY)
02.2020 - 03.2025
Validation & Compliance Analyst – Life Sciences
Accenture Solutions Pvt Ltd
07.2017 - 02.2020
Bachelor of Engineering - Electrical And Electronics Engineering
B. M. S. College of Engineering
Higher Secondary / Pre-University / 12th Grade -
Al-Ameen PU College
High School Diploma -
St. Joseph's Convent High School