RAJIV KUMAR

I am a seasoned professional in the field of Quality Assurance, specializing in regulatory compliance and quality management. With a diverse background spanning various organizations, have held key roles that have equipped with a broad skill set. I have began as a Quality Executive at IMA Blood Bank in India, where I spearheaded the implementation of ELISA testing, enhancing my expertise in quality control procedures, documentation, and audit processes.
Building on this foundation, I progressed to the position of Quality Assurance Manager at Cryoviva Biotech Pvt Ltd. in India. In this role, I conducted audits based on stringent checklists including DCGI, ISO, NABL, AABB, CAP, cGMP, and cGLP. This role required a meticulous approach to quality analysis, laboratory equipment management, and documentation practices.
Currently serving as the Senior Manager of Quality Assurance at Cryoviva Singapore Pte. Ltd (CSG), I oversee a wide array of responsibilities. These include leading external and internal audits in compliance with MOH Singapore regulations, CSG SOPs, ISO 9001-2015 Quality Management System, and AABB Cellular Therapy standards. A vital aspect of my professional development has been my dedication to training and enhancement. I have completed the AABB Assessor Course, enhancing my skills in maintaining high-quality standards in cellular therapy assessments. Additionally, I have pursued training in Quality Management Systems, ISO standards, bio safety principles, and internal auditing, among other areas.
I am committed to upholding the highest standards of quality and regulatory compliance in all aspects of my work, and I continuously seek opportunities for professional growth and development in the field of Quality Assurance.

• Quality Management System And Audit Plan as per ISO 9001:2008
• Quality Management System And Audit Plan as per ISO 15189:2007
• Quality Management System And Audit Plan as per ISO 15189:2012
• Quality Management System organized by Bio-Rad Laboratories
• Biosafety Principles and Procedure(BSL-2) by Temasek Lifesciences Singapore
• 9001:2015 Quality Management System Internal Auditor Training Course by SGS Singapore

- Lead role in audit preparation, presenting QA documents to auditors and providing satisfactory explanations.
- Stay updated on regulations and standards, and drive the implementation of new processes.
- Conduct internal audits, establish quality objectives, oversee new projects and products, validate processes, and ensure compliance.
- Independently supervise all audits and perform in-process quality assurance checks.
- Issue line clearances at each stage of batch manufacturing and maintain updated Batch Manufacturing Records.
- Review logbooks, calibration records, IQC records, BPRs, temperature and humidity records, etc.
- Provide supervision in the production.

• Quick learner
• Positive attitude
• Good interpersonal skills
• Always helping to others who are in need and if i am able to help.

Successfully completed the AABB Assessor Course and subsequently promoted to Assessor Team Member following the successful completion of two AABB assessments as a volunteer assessor.

ISO 9001 QS Internal Auditor

https://www.aabb.org/standards-accreditation/accreditation/assessor-information/assessor-q-a-rajiv-kumar

https://www.aabb.org/news-resources/news/article/2023/07/25/maximizing-quality-assurance