Ayesha Rasheed

Master's

Business Administration

Siemens Healthcare Diagnostics

Senior Manager

- Successfully participated in Site Quality Transformation plan (QTP) 2 year long project to align standard operation procedures, and other quality records with Siemens sister sites for due to FDA regulation - Product management skills with managing over 100 product line for the department of Biochemistry - SAP in depth knowledge from implementation to site expert for planning and production - Strong project management skills with management of monthly >30 Manufacturing project - Knowledge of continuous improvement and regulatory submission - Understanding of DMAIC, lean and Sigma methodologies - Responsible for review and approval of departmental Quality record prior to submission to Quality review board - Responsible for leading the department in implementing quality management system - Responsible for periodic review of department's standard Operating procedures - Lead the department in process improvement, lean manufacturing, and quality driven organizational goals - Experience in leading root cause analysis, , implementing preventive or corrective action - Responsible for continuous improvement using several lean manufacturing techniques leading to >$3 million dollars of productivity measures - Successfully led validation/verification project for large scale purification process within the department leading to >$2 million dollars in savings which led to the team receiving multiple reward and recognition from the organization. Successfully led validation/verification project for large scale purification process within the department leading to >$2 million dollars in savings which led to the team receiving multiple reward and recognition from the organization - Member of Quality review board as subject matter expert - Responsible for overseeing all projects submitted for change impact assessment including risk assessment - Responsible for preparation of all internal and external audits. Complete internal audits for continuous improvement and cGMP - Responsible for overseeing three groups within the department of Biochemistry. It includes Laboratory Operation, Analytical and evaluation testing, and critical reagents manufacturing - Responsible to decision making approve or reject of procured material internal specification/test standards - Responsible for ensuring quality products are delivered on time every time to internal customer - Knowledge of dangerous goods subject to transport, workplace, storage, consumer, and environmental protection regulations - Knowledge of Globally Harmonized system of classification of chemicals (GHS) and the UN recommendation on the transport of dangerous goods regulations (TDG - Head of SAP implementation plan involved 5 leading 5 different departments. 2 years project - As part of SAP implementation introduced - 800+ new part numbers, built bill of materials, routings, and material master - Successfully lead several quality driven programs for the organization such as Quality plan to improve Manufacturing batch records, Standard Operating procedures. Function testing quality plan site to site within Siemens organization - As member of Validation review board, responsible for all departmental validation/verification and development protocols - Member of CAPA review board, and responsible for overseeing departmental CAPA assigned - Responsible for overseeing and reporting to Quality Review Board quality metrics for Los Angeles site Manufacturing Support - Experienced in project management - Experienced in working with cross functional teams to accomplish organizational targets/KPI - Responsible for preparation of department annual budget including head count