Selvaraj Kumar Ananthramakrishnan

Lead Quality Assurance & Regulatory Affairs

• Job Details:Led enhancements to the quality management system (QMS) in compliance with ISO 13485 & 21 CFR 820, achieving a 90% improvement in process efficiency. Planned and executed internal and external audits, resulting in a 98% audit pass rate. Directed and optimized document control processes, overseeing comprehensive updates to SOPs, forms, checklists and templates, etc., reducing errors by 20%. Collaborated with cross-functional teams (CFTs) to define and implement quality objectives and metrics to drive continuous improvement. Ensured regulatory compliance by proactively monitoring and interpreting applicable regulations and standards, leading to a 20% reduction in non-conformances. Implemented and strengthened risk management frameworks, leading to an 18% reduction in risk exposure across product development and manufacturing. Authored, reviewed, and submitted regulatory documentation with 100% accuracy and completeness, ensuring full compliance with health authority requirements. Oversaw validation and verification activities, ensuring processes and products met stringent quality standards, resulting in a 20% decrease in defects and errors. Led and resolved customer complaints by conducting root cause analysis (RCA) and implementing corrective and preventive actions, improving resolution time by 20%.

Senior Executive

• Job Details:Investigated deviations/non-conformities and ensured effective CAPA implementation. Led audits and maintained a defect-free plant with zero product recalls.

Pharmaceutical Technician

• Job Details:Ensured quality compliance alongside cross-functional QMS teams. Coordinated with the data integrity team for implementation of ALCOA principles.