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 methodsCompliance :• 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;