Hire Talented Quality Assurance (GxP) Documentation Specialists

Quality Assurance Manager

Vinay Pillai is a Quality Assurance Manager with over 11 years of experience in Computer System Validation (CSV), eCompliance, and GxP-regulated systems across the pharmaceutical and biotechnology industries. He specializes in validation lifecycle management, regulatory inspection readiness, quality oversight, and compliance for enterprise and manufacturing systems. Vinay has deep expertise in 21 CFR Part 11, GAMP 5, CSV strategy, change control, CAPA management, and cross-functional collaboration with QA, IT, and business teams. With extensive hands-on exposure to Veeva, ServiceNow, LIMS, EDMS, SAP, DeltaV PCS, MES, OSI PI, and multiple validation/testing platforms, he consistently ensures regulatory alignment and drives continuous quality improvement across global operations.

Validation & Compliance Lead

Harsh Kanojia is a Validation & Compliance Lead with 11 years of experience in Computerized System Validation (CSV) across global pharmaceutical and life sciences organizations including Novartis, GSK, Johnson & Johnson, Sanofi, Zoetis, and Purdue Pharma. He specializes in GxP system validation, SDLC management, GAMP 5 methodologies, testing, documentation, and regulatory compliance aligned with US FDA, EMA, 21 CFR Part 11, and Annex 11 guidelines. Harsh has extensive hands-on expertise with validation deliverables, risk assessments, test management, change control, audit trail reviews, and GRC tools. He excels in leading validation projects, managing quality operations, and ensuring end-to-end compliance across IT and manufacturing systems.

Senior Executive in Quality Assurance

Birendra Das is a Senior Executive in Quality Assurance with over 8 years of experience in the pharmaceutical and biotechnology sectors, specializing in GxP compliance, microbiology, and quality systems implementation. He brings strong expertise in deviation and CAPA management, regulatory audit readiness, validation documentation, and data integrity in FDA, EMA, WHO, and MHRA-regulated environments. Skilled in QMS operations, change control, microbial testing, and validation of cleanroom and cell bank processes, Birendra ensures robust compliance and process sustainability. With hands-on experience using LIMS, TrackWise, and eVALGENESIS, he delivers consistent quality oversight across manufacturing and microbiology operations.

Quality Assurance and Computerized System Validation (CSV)

Bhavana Reddy is a Quality Assurance and Computerized System Validation (CSV) professional with 12 years of experience in regulated pharmaceutical and biotechnology environments. She specializes in validation lifecycle management, risk-based validation, LIMS master data configuration, and implementation of GxP systems compliant with GMP, GAMP 5, 21 CFR Part 11, FDA, EMA, and ICH guidelines. Bhavana excels in managing quality systems, authoring validation documentation, and ensuring data integrity across critical systems. With strong cross-functional coordination and deep domain expertise in QMS, CAPA, and regulatory compliance, she delivers reliable, compliant, and business-aligned system validation solutions.

Senior Manager in Governance, Risk & Control

Akshay Kumar is a Senior Manager in Governance, Risk & Control with over 14 years of experience in Quality Systems, Regulatory Compliance, GxP Validation, Risk Management, and Data Integrity. He leads global cross-functional teams in large-scale quality transformations, risk-based validation programs, and audit readiness initiatives across pharmaceutical and biotech environments. Skilled in developing governance frameworks, optimizing quality processes, and ensuring alignment with FDA, EMA, and ICH guidelines, Akshay consistently delivers high-impact compliance solutions that strengthen organizational oversight and regulatory readiness. His expertise spans QMS oversight, CAPA management, vendor audits, computerized system validation, and digital quality system implementations such as Veeva and TrackWise.