B. Kumar Singh Email & Phone Number

Results-driven and accomplished Quality Assurance professional with comprehensive experience in Pharmaceutical industry in APIs (drug substance)/ bulk drugs. Expertise to develop, implement and maintain effective quality systems, ensure compliance with global regulatory requirements. Driving continuous improvement and achieving organizational goals.1. Served as the Subject matter expert (SME) in investigating and resolving Out of Specification, Out of trend results, Out of expectations, unknown peaks, deviations and customer complaints. Reduced investigation timelines by streamlining the investigation process. Implemented robust CAPAs to reduce the repeated OOS/ OOT and decrease in the frequency of OOS/ OOT events. 2. Served as the Subject matter expert (SME) in evaluating the changes and their implications. Developed and implemented cost-effective alternatives within change control processes, reducing commercial implications without compromising product quality or regulatory requirements. 3. Spearheaded Nitrosamines/ NDSRI, PGI assessments in line with evolving FDA, EMA guidelines4. Successfully prepared and facilitated regulatory inspections (USFDA, EDQM, EMA – QP, MHRA, Health Canada, TGA, PMDA, KFDA, COFEPRIS, ANVISA, WHO, CDSCO, DCA). Involved in the FDA 483 response writing, independent gap assessments and remediation plans. 5. Posses in-depth knowledge and expertise in global regulatory aspects as per ICH, USFDA, EU, WHO and others. 6. Skilled in establishing and harmonizing robust quality systems, performing risk assessments, new product launching, managing vendor/ CMU qualifications, developing and implementing Quality Improvement Plans, validation and qualifications, training and development activities. 7. Expediting the quality activities by identifying and optimizing key cost drivers.