Thanabalan Subramanian

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, Thana has a Masters in Advanced Manufacturing Systems. Over 28 years of validation 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, and lab, clinical, PV & process control systems. An ISPE member since 2001, Thana is currently the Chair of the ISPE GAMP CoP Europe Steering Committee and is also Global Steering Committee & CSA SIG member. Continues to support ISPE GAMP CoP UK steering committee since 2010 as a member, having held Secretary, Co-chair and Chair roles.