Thanabalan Subramanian, Head of Quality at Integrity & Secretary, GAMP Global Steering Committee

Thana’s current role is Head of Quality at Integrity. Responsible for the Quality Services organisation covering CSV compliance projects (prospective & remediation), Audit management, Data Integrity programmes, training and organisation design/change. Having previously worked for Otsuka, Roche, GE Healthcare, GSK, GlaxoWellcome & Merck Sharp & Dohme.

Originally qualified as a Chemical Engineer, has a Masters Advanced Manufacturing Systems.

30 years of industry experience, the majority being focused on CSV across all the GxP’s with experience of Steriles, Primary & Secondary manufacturing, and R&D, (pre-clinical, clinical, pharmacovigilance & manufacturing).

An experienced auditor and practitioner of CSV projects, ranging from spreadsheets to SAP, laboratory, clinical, PV & process control systems.

Secretary for the ISPE GAMP Global Steering Committee. Former Chair of the ISPE GAMP CoP Europe Steering Committee. Also, a member of the ISPE GAMP CoP UK, eClinical SIG and CSA SIG. Member of the IT committee for the Research Quality Association (RQA)