Parvesh Dabur

Team Lead for QA Operations at Dynavax GmbH - Bioprocess / Fermentation based vaccine antigen (HBsAg) production - Leading the QA Ops with ownership for key compliance metrics (Deviations /Investigator Certification Program, CAPAs, ECs), OOS/OOE, Change Controls, Complaints, and Recall handling. - MAH expansion QA for EU/UK (for Heplisav-B) - Change / Site Development CAPEX projects: GMP Facility Expansion / Equipment Upgrades - eQMS: TrackWise admin / modules development

- Led QA (GxP) compliance team: Site's QMS, KPIs, Quality Plan, Document Management, Compliance, DI and eCompliance, Supplier Management, Complaints Handling, Engineering QA, Launch QA, Change Control Management -Back office lead and organization of HA (US FDA with 0 483s), internal, and customer audits -Drove organizational change management, and digitalization, to establish an agile team.

- Global product escalations (GxP relevance) and Risk Assessment: Deviations, Complaints, OOS - Market actions (Withdrawals, Recalls): Global QA assessment and management - Warning letter/Compliance/Regulatory issues: Remediation, CAPAs and HA communications - CMOs and Supplier management - GxP Data integrity issues management including Quality Management Systems - Process ownership: Global management escalations (GxP), FAR/BPDR, Market actions and process specific TrackWise tool implementation.

Pharmaceutical QA and TechOps (Oct 2012) - Analysis and process harmonisation: Product holding times, Packaging testing - CAPA Management, LIMS Biopharmaceuticals QA (July 2013) - Project management: CAPA management, TrackWise - Technical complaints (biosimilars) - IMP (Investigational Medicinal Products) & Clinical trials Pharmaceuticals QA (Feb 2014) - Process validation and equipment - Commissioning and qualification - Project Management: Global CAPA management

- Business Development - Brand Analysis, Management and Launch - Biochemical reagents - Market Analysis

- Working at Roche Applied Science (Custom Biotech) - B2B Industrial Marketing - Portfolio Analysis - International Marketing

-Worked as a part of TCoE (Testing Center of Excellence) team supporting “Bank of America” - Skilled for project management (DMAIC and V-Model) and functional testing (using Quality Center as the testing tool, QTP as an automation tool) - Resource management - Daily Dashboard Reports, Project Status Reports - SharePoint, IT - Six Sigma training (online)

International Marketing Project Management Product and Brand Management Strategic Management

Biotechnology, Bioprocess Engineering, Immunology, Microbiology, Cell Biology, IPR