Lokesh K M

Results-driven Quality Assurance Manager with extensive expertise in cGMP, US FDA, and EU GMP compliance for API manufacturing.ing. Skilled in SAP S/4HANA MM (vendor management, procurement, inventory), ISO 9001:2015 QMS, audit leadership, and CAPA management. Proven ability to lead lean process improvements and digital transformations to enhance quality and operational excellence. Strong technical knowledge of Active Pharmaceutical Ingredients synthesis, risk assessment, and ERP systems, combined with effective stakeholder communication, and team leadership. Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

• SAP S/4HANA MM Consultant, July 2025
• CQI & IRCA, Singapore Certified ISO 9001:2015 QMS Lead Auditor, February 2021
• Integrated Management System awareness and audit techniques, MS Quality Management Service, Hyderabad, December 2017

Currently enrolled in Lean Six Sigma Green Belt certification, and advancing proficiency in SAP QM, Excel functional formulas, and ICH guidelines. These efforts reflect my dedication to enhancing my expertise and aligning with industry best practices for pharmaceutical quality assurance. Although I encountered career gaps due to differences in quality perspectives with previous management, I proactively chose to move forward in search of an organization where I can fully apply and further develop my skills. I am motivated by continuous learning and excited to contribute to a dynamic company that values quality, compliance, and operational excellence

• Active involvement in Christian ministries, contributing to community service, and spiritual growth
• Passionate about translation work, enhancing cross-cultural communication, and language skills
• Enjoy teaching children, fostering education, and mentorship outside the professional environment
• Enthusiastic about cooking creative dishes using available ingredients, focusing on delightful aromas and flavors that reflect creativity and resourcefulness

• Led quality assurance teams through three consecutive USFDA inspections with zero observations, ensuring full regulatory compliance and operational excellence
• Successfully reduced operational deviations by 18% through targeted process improvements and CAPA implementation
• Promoted to deputy manager and manager roles within quality assurance due to consistent performance, leadership in audit readiness, and process optimization
• Spearheaded SAP S/4HANA MM system integration for materials management, significantly improving inventory accuracy and compliance traceability
• Certified ISO 9001:2015 QMS Lead Auditor (IRCA Singapore), leading multiple successful audits for US FDA and EU GMP compliance
• Recognized for excellence in training and mentoring quality assurance staff, resulting in improved team performance and readiness
• Awarded for driving lean and continuous improvement initiatives that enhanced workflow efficiency and reduced waste in API manufacturing.