Ashu Ashu

• Coordinated with project teams and departments to provide support for various quality assurance inputs. • Handled customer complaints and coordinated with cross-functional teams to resolve quality issues by ensuring CAPAs are systemic in nature and eliminating the root cause and non-conformities. . Developed various quality assurance program and plans according to ISO compliance. • Responsible for QA management while supporting the implementation of process with respect to ISOs, and SOPs.

• Managed portfolio of products from clients for regulatory requirement, validate plans and reports • Delivered quality assurance projects to meet compliance and qualification of product components for country registration processes- US, Germany and other EU. • Implementation of change and deviation management (CAPA – Corrective measures, RCA, Fishbone) and internal audit plans. • Reviewed processes for implementation of product design-related SOPs to marketing needs, and handled change control processes.

• Project management for Intel Co. - generated audit reports and patent filing, IP management and delivered portfolio transition projects. • Managed key accounts for clients, including quality management of project deliverables on periodic basis while organizing data and providing complex reports.

• Management and development of financial, non-financial and annuity policies for US clients. • Responsible for process training, analysis reports for audits, management of external stakeholders

• Managed key accounts, quality matrices, budget planning and overall project coordination with internal and external stakeholders.