Lakshman Prakash Balajepalli
Head-Quality & Regulatory
RAS Lifesciences Pvt. Ltd., (a Biomerieux group company)
India
Biography
A life sciences professional with experience in manufacturing and quality departments. Moved up the ladder as Vice president and later as Head-Quality and gained experience in Quality systems, Projects, operations management. These experiences gave me opportunities and immense knowledge, opportunities to prove and validate my capabilities in Man management as well as all aspects of lifesciences Present job profile has added knowledge and experience in international best practices in quality systems, project and operational management for running an organisation. A Certified Internal auditor for ISO 13485, ISO 15189 quality systems , experienced in ISO 14971, Risk Assessment, ISO 62034. International experience as Consultant for QMS systems for Biotech Company Member of team as Subject matter expert for due diligence in-vitro Diagnostics Company. Experienced in regulatory approvals as per CDSCO guidelines, WHO of human vaccines and CE guidelines for medical devices –IVD reagents and equipments
Research Interest
Vaccine process optimization and development and IVD Product development