Subajini Selliah

Background

About Subajini Selliah

M. Sc. Microbiologist with over 20 years of experience in the biotech industry operating in positions of QA/QC Project Manager and Compliance, Head of QC in Regenerative Medicine and Scientist in drug discovery programs from target identification/validation to clinical candidate nomination. Ms. Selliah has a strong background in conducting compliance projects in the healthcare, biosafety, validation, natural products, biotechnology and regenerative medicine sectors. EXPERTISE: QA/QC : • CCS/CCP • Industrial validation of production equipment and QC • Cannabis industry performance evaluation • Vaccine technology transfer • Implementation and improvement of quality management systems: non-conformities, deviations, change control, CAPA, OOS/OOT • Documentary organization and QC compliance documentation (procedures); • Development of registration files (NPN/DIN) • Supervision of the QC laboratory; • Writing of study reports, CofA and analytical methods; • Management of the manufacturing process to ensure compliance with specifications and limits; • Validation of analytical methods Compliance : • Advise and support compliance as a Canadian and European biosafety institutional trainer; • Drafting of study reports and analytical methods; • Validation of analytical methods; • Implementation of programs: training, metrology, maintenance, stability; • Apply for PHAC and CFIA licenses for BL2 and BL3 laboratories; • Participate in BL3 design and functional installations; • Implementation and organization of documents;