Duraisamy Rajan Palani, MS
Deloitte & Touche LLP
Advisory Senior Manager
Durai is a passionate life sciences entrepreneur with 17+ years of experience in pharmaceutical contract manufacturing & quality, computerized systems validation (CSV), 21 CFR Part 11, GAMP5 and software quality assurance / testing. He is a member of the ISPE India GAMP Steering Committee.
As the Director of Quality and Strategy and a Member of the Board of Directors at Archimedis Healthcare Private Limited, Durai heads the firm’s Quality, Strategy and Software Business organizations. At Archimedis, Durai played a vital role in obtaining MHRA accreditation for the manufacturing facility and led the development and implementation of eCapsule (a GxP software for ERP, factory automation and GxP process controls).
Before joining Archimedis, Durai was managing the Software Quality processes and platforms for a global top 10 life sciences organization, headquartered in New Jersey, USA. He was responsible for the implementation of common testing process framework and eSignature that standardized the software testing process for GxP and non-GxP systems across 200+ operating companies.
As part of his progressive career, Durai has consulted 25+ life sciences corporations globally, across pharmaceutical, bio-technology and medical device domains.
Durai holds Master of Science (MS) degree in software engineering from Birla Institute of Technology and Sciences (BITS, Pilani, India). Durai has also held certifications such as Project Management Professional (PMP), PRINCE2 Practitioner and Certified Software Quality Analyst (CSQA).
As the Director of Quality and Strategy and a Member of the Board of Directors at Archimedis Healthcare Private Limited, Durai heads the firm’s Quality, Strategy and Software Business organizations. At Archimedis, Durai played a vital role in obtaining MHRA accreditation for the manufacturing facility and led the development and implementation of eCapsule (a GxP software for ERP, factory automation and GxP process controls).
Before joining Archimedis, Durai was managing the Software Quality processes and platforms for a global top 10 life sciences organization, headquartered in New Jersey, USA. He was responsible for the implementation of common testing process framework and eSignature that standardized the software testing process for GxP and non-GxP systems across 200+ operating companies.
As part of his progressive career, Durai has consulted 25+ life sciences corporations globally, across pharmaceutical, bio-technology and medical device domains.
Durai holds Master of Science (MS) degree in software engineering from Birla Institute of Technology and Sciences (BITS, Pilani, India). Durai has also held certifications such as Project Management Professional (PMP), PRINCE2 Practitioner and Certified Software Quality Analyst (CSQA).