Goutam Debnath

Strategic SAP & IT Compliance Leader with 15+ years of experience in Pharmaceutical and Life Sciences environments. Expertise in SAP MM & QM implementation, validation strategy, risk-based testing (GAMP 5), 21 CFR Part 11 compliance, and global regulatory audit readiness. Proven leader in managing enterprise SAP lifecycle, cross-functional teams, and multi-site compliance programs.

Sr. Specialist, IT Quality & Compliance - BAXTER - Bangalore

(2019-08)

• SAP Program Lead overseeing ERP validation across Manufacturing and Quality domains.
• Directed SAP MM & QM implementation, validation master planning, and lifecycle governance.
• Managed 50+ annual SAP change controls with zero critical regulatory observations.
• Reduced validation cycle timelines by 30% through risk-based testing optimization.
• Led infrastructure qualification and SAP cloud compliance initiatives.
• Supported inspections (FDA, TGA, MHRA, WHO, Health Canada).

Sr. Test Lead - KPIT Technologies - Bangalore

(2018-06 - 2019-07)

• Managed SAP validation lifecycle using HP ALM.
• Delivered compliant documentation aligned with GxP and FDA standards.
• Led SAP integration and remediation programs.

Sr. Project Validation Specialist - Ivy Works Advisor - Bangalore

(2015-11 - 2018-05)

Clients Details: Sun Pharmaceuticals Ltd, Strides Shasun, Alembic, Tenshi.

• Ensured compliance with regulatory standards and validated computer systems in laboratory and manufacturing environments.
• Validated PLC, HMI, and SCADA-based equipment.
• Prepared and reviewed validation protocols, including IQ/OQ/PQ documentation, Validation Protocols (VP), Validation Summary Reports (VSR), Standard Operating Procedures (SOPs), and risk assessments.
• Developed and reviewed User Requirement Specifications (URS), Functional Requirements Specification (FRS), and Requirement Traceability Matrix (RTM) documents.
• Executed IQ, OQ, and PQ test cases.
• Prepared validation deliverables such as VP, IRA, URS, DS or CS, TP, FRS, FRA, IQ, OQ, PQ, RTM, and VSR.
• Applied knowledge of GLP, GMP, and GAMP V guidelines.
• Ensured compliance with 21 CFR Part 11 and GxP FDA Regulations for computer systems.
• Prepared 21 CFR Part 11 checklists.
• Demonstrated knowledge of MES software development and validation deliverables.
• Validated software systems such as LIMS, SAP, EMPOWER, and Non-CDS systems.
• Reviewed controls on application, OS, database, and network.
• Worked under Category 1, Category 3, and Category 4 risk-based approach software (CDS and Non-CDS).
• Prepared SOPs related to administrative security policies on software, backup, and restoration of electronic data.

CQA (QA EXECUTIVE) - Adcock Ingram Health Care - Bangalore

(2015-01 - 2015-11)

• Third party Manufacturing equipment validation
• Preparation of BMR and BPR
• Preparation and review of qualification documents and (protocol and report)
• Preparation and review of validation documents (protocol and report)

QA Executive - Micro Labs - Bangalore

(2010-05 - 2014-09)

• Equipment validation, GMP documentation, change control, and deviation management.
• Preparation of validation protocols, reports, SOPs, and regulatory documentation.

B.Pharm - Karnataka College of Pharmacy

D.Pharm - Acharya College of Pharmacy