Head Of Research And Development
Current• As a Project Leader, responsible for design, execution & development of differentiated, high quality molecular IVDs as per international norms. • Preparation of Project Plan, design inputs & outputs, Specifications, QC strategy & other important project related documents.• Preparation, review & approval of SOP’s, GLP & GMP documents (e.g., Analytical methods, CAPA procedure, Environmental monitoring, analytical instrument qualification reports, etc.)• Investigate, analyze, troubleshoot, review & present scientific/technical results to regional & global teams. Foster scientific mindset & innovation in the team. • Facilitate the Technology Transfer, ensuring that products moves efficiently from R&D to production. • Responsible for collaboration with referral centers for Verification & validation studies, prototype preparation, performance evaluation studies, self-life evaluation of IVD products in molecular diagnostics with focus on safety, cost, quality, and customer service. • Collaborate with other departments and R&D centers to ensure that assay methods meet product requirements and regulatory standards.• Comply with the requirements of the QMS and ISO 13485:2016 standards. Ensure SOP compliance training for the team to fully comply with QMS.• Actively participate in cross-functional team meetings to update on agreed activities and milestones. • Support the CE-IVD marking of products required in close collaboration with the global, regional & local Regulatory function & promptly delivers all relevant design & development documents. Familiar with India & EU IVD regulations.• Customer engagement: Engage with internal & external stakeholders to build effective relationships.• Manage & keep up to date all required permissions (e.g. IBSC RCGM) statutory approvals & licenses.• Representation of the organization at national & international scientific forums & brand recognition in the IVD space as a quality developer & manufacturer of molecular assays.
