Karthi Robert

Led the strategic qualification of Grade A / sterile processing zones, validating terminal
sterilization and aseptic techniques to secure 100% compliance with EU Annex 1 and USFDA
guidelines.
Governed contamination control strategies (CCS) and environmental monitoring
frameworks, successfully mitigating bioburden risks to reduce shop-floor deviations by 15%.
Architected and governed the corporate IPQA strategy across 34 high-complexity
manufacturing facilities and cleanroom laboratories to enforce total shop-floor
compliance.
Directed a 90+ member cross-functional QA/QC division, optimizing floor surveillance
workflows to sustain 100% equipment readiness and operational excellence.
Championed regulatory excellence and audit readiness, securing an absolute 100% pass
rate across high-stakes, unannounced inspections by the USFDA, WHO, EMA, and MHRA.
Cultivated proactive quality culture through deployment of sterility assurance and
operational controls, mitigating critical risks and reducing recurring deviations by 15%.

Led the strategic qualification sterile processing zones, validating sterilization and aseptic techniques to secure 100% compliance guidelines.
Governed contamination control strategies (CCS) and environmental monitoring
frameworks.
Governed the corporate IPQA strategy cross manufacturing facilities and cleanroom laboratories to enforce total shop-floor compliance.Directed a 90+ team memberoptimizing floor surveillance workflows to sustain 100% equipment readiness and operational excellence.
Regulatory excellence and audit readiness, securing an absolute 100% pass
rate across high-stakes, unannounced inspections by the USFDA, WHO, EMA, and MHRA.

• Multi-Site CQV Operations: Masterminded multi-site Commissioning, Qualification, and Validation programs for critical clean utilities, process systems, and sterile formulation streams across multiple cGMP plants.
• Lifecycle Management: Authored, executed, and archived comprehensive validation lifecycles including DQ, IQ, OQ, and PQ baselines in close technical orchestration with international engineering EPC contractors.
• Regulatory Submittals: Compiled and reviewed key regulatory technical filings including Batch Manufacturing Records (BMR), Annual Product Quality Reviews (APQR), and Master Validation Plans with zero critical findings.
• Accelerated project delivery timelines by 45% through implementation of parallel testing tracks and structured, risk-based script execution methodologies, enhancing overall project efficiency.
• Coordinated technology transfers for multi-stage product transitions, establishing standard baseline operational parameters to maintain zero manufacturing downtime and ensure compliance.
• Supervised daily shop floor QA teams, monitored discrepancy tracking, executed rapid root-cause analyses, closed complex site change controls, and performed extensive gap analyses to ensure compliance with quality standards.
• Adcock Ingram (Johannesburg, SA) | Global Pharmatech
• Build and maintained strong relationships with partners and key stakeholders.
• Fostered collaboration among cross-functional teams for project success.