Naresh Kumar
About Naresh Kumar
Naresh Kumar is a Validation Specialist at Alkermes with extensive experience in process validation and technology transfer in the pharmaceutical industry.
Current Company and Role
Naresh Kumar is currently employed at Alkermes as a Validation Specialist based in Ohio, United States. His role involves working on various validation projects, ensuring the robustness and compliance of manufacturing processes, specifically in the area of MS&T process validation and technology transfer.
Previous Professional Experience
Naresh Kumar has a significant background in validation engineering and analysis, having worked at multiple prestigious firms. He served as a Validation Engineer at Amgen Pharmaceuticals in California from 2016 to 2020. Prior to that, he held the position of Validation Analyst at GlobePharma, Inc. in New Jersey for 10 months between 2015 and 2016. His career started at Akron Bio, where he worked as a Validation Analyst from 2013 to 2015.
Education and Expertise
Naresh Kumar graduated from Anna University with a Bachelor's degree. He has accumulated over six years of experience in process validation, technology transfer, and quality control. His skill set includes reviewing and executing validation protocols, managing site validation master plans, and conducting quality audits. Naresh is well-versed in GMP and GDP practices and compliance with regulatory guidelines.
Specialized Skills and Knowledge
Naresh possesses in-depth knowledge of manufacturing equipment and processes used for Parenteral and Ophthalmic solutions. He is skilled in monitoring Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) through continued process verification programs. Additionally, he has prepared, analyzed, and resolved deviation reports and change controls. His expertise extends to using statistical analysis tools like Minitab and executing facility and equipment qualifications (IQ, OQ, PQ).
Quality Assurance and Compliance Work
Naresh Kumar has a comprehensive background in quality assurance and regulatory compliance. He has reviewed Annual Product Reviews (APRs) and product performance, drafted and trained users on Standard Operating Procedures (SOPs), and managed Laboratory Validation Systems, including Temperature Mapping and QMS development. He has proven experience in process validation batch execution, protocol preparation, and report writing, along with strong problem-solving abilities and effective communication skills.