Technical Transfer Lead
July 2014 --- February 2016
• Provided end to end leadership to cross-functional transfer team for manufacturing process and product transfers within and between the sites. • Led regular stand-up meetings, events and continuous improvement projects with measurable goals. • Ensured that all related global standards (WHO &ICH) are set and applied in all transfer activities. • Developed and implemented data-based solutions in a timely manner. • Maintained manufacture and supply of high quality products over the course of product lifecycle. • Implemented root cause and corrective actions to remove production constraints and improve product quality. • Led improvement projects to boost productivity, quality and overall manufacturing process efficiency. • Defined manufacturing performance standards and reviewed the performance outcomes to set future targets. • Identified staffing and capital needs, collected relevant data and wrote justifications for established needs. • Managed technical aspects of manufacturing transfer of products site to site. • Led manufacturing transfers from 3rd parties and new products from R&D. • Included oversight of scale up, setting and application of critical process parameters that adhere to the appropriate technical standards. • Followed Pharmaceutical industry standards, Regulatory and company Quality requirements in generating and updating supporting documentation. • Coordinated and implemented IQP (Innovation-Quality-Productivity) programs.
Manufacturing Process Coordinator
November 2008 --- July 2014
• Planned, organized and coordinated all shop floor activities in order to meet customer demands. • Identified inefficiencies and made recommendations for process improvements. • Enforced a culture of lean manufacturing and continuous improvement while providing operational leadership. • Mentored, coached and trained employees to develop a high performing team. • Identified staffing and capital needs, collected relevant data and wrote justifications for established needs. • Defined manufacturing performance standards and reviewed the performance outcomes to set future targets. • Reviewed production orders, delivery dates and inventory levels to determine product availability. • Supervised production schedules, production quality and on time delivery. • Led regular stand-up meetings, events and continuous improvement projects with measurable goals. • Implemented root cause and corrective actions to remove production constraints and improve product quality. • Improved efficiency and productivity by eliminating waste in production and packaging processes. • Budgeted monthly departmental expenses and implemented cost controls. • Completed key projects on time, on budget and with a high level of accuracy. • Organized, prioritized and managed plant maintenance projects to keep facility safe, efficient and clean. • Developed and maintained strong and clear communication and rapport with employees.
July 2007 --- November 2008
• Implemented and provided oversight of quality systems to assure conformance with policies, standards and specifications. • Ensured a robust quality system is in place that guarantees product quality, identity and traceability throughout the supply chain. • Communicated and implemented global procedures, policies and guidelines at local level and third party manufacturing sites. • Ensured alignment with global and standardized practices across the site. • Tracked, identified key trends and reported quality systems performance. • Performed deep dive analysis to identify opportunities and make recommendations for improvements. • Prepared regular quality scorecard reporting to Global Senior Leadership. • Conducted operational excellence and efficiency within Quality Operations using Lean methodologies. • Led teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WIs). • Developed and implemented strategies and tools for tracking contractors’ performance. • Ensured effective change control and effective risk management to prevent unanticipated failure modes. • Implemented and monitored process capability for continuous improvement. • Investigated and resolved quality related issues and implemented CAPAs. • Developed, implemented and managed a comprehensive GxP Inspection Readiness Program. • Coordinated and led remediation projects for compliance gap and risks. • Collected and compiled all necessary data in order to prepare APR/PQR (Annual Product Quality Review). • Executed deviation investigations prior to final decision for Batch Release as Qualified Person.
January 2000 --- July 2007
• Planned, directed and coordinated the production activities. • Ensured product outputs in parallel with quality requirements through established KPIs by remaining on budget. • Supervised production processes for an entire plant. • Coordinated shop floor activities, adjusted work assignments to meet customer demands. • Determined the priorities according to production plan. • Implemented and led improvement projects to increase productivity and efficiency. • Monitored and reported production KPIs on a regular basis. • Ensured production consistent, established and monitored the methods used. • Implemented policies and procedures for production operations. • Established production standards through the implementation of quality systems. • Conducted performance appraisals and new staff orientation. • Implemented employee training and development program. • Applied advanced statistical tools and methods to fix quality control issues. • Performed deviation handling, Root Cause Investigation and implementation of CAPAs. • Managed and evaluated manufacturing system changes for quality and reproducibility.
Lead Quality Assurance Engineer
June 1997 --- December 1999
• Monitored and inspected day-to-day factory floor activities. • Reviewed and evaluated In Process Controls performed by quality technicians. • Ensured adaptation of manufacturing process in order to comply with the specifications. • Provided guidance to shop floor and other roles that impact product quality. • Trained the production staff and operators in updated work instructions and procedures. • Acted as the liaison to customers and suppliers. • Defined methods and equipment that will be used to measure key quality characteristics. • Identified and led improvement opportunities as determined through data analysis, customer audits and other quality-related programs. • Ensured quality system tools are validated throughout the plant quality architecture. • Investigated and reported customer complaints through allocated resources.
Analytical thinkingApproachabilityAttention to detailAssertivenessCommunicativeCollaborationCoordinationEfficiencyCuriosityFlexibilityInnovative thinkingInterest in knowledgeOptimismProactivityProblem solvingResiliencyResult OrientedSelf-confidenceSelf-disciplineStrivingTrustStrategic thinkingResponsibilityAdaptability
Skills and Expertise
Create SOPs Analytical skills Develop protocols Lab scale batchesCalculate process efficiencyCollaborate with project teamCoordinate projectsImplement Quality Management System (QMS)Implement Key Performance Indicators (KPI's)Manage complexityManage data collection systemManage global quality standardsManage projects resourcesManage risksManufacture of GMP batchesMonitor Key Performance Indicators (KPI's)NegotiationPeople managementPilot scale batchesproject managementProvide trainingProvide technical supportRegulatory submissionsReport Key Performance Indicators (KPI's)Train StaffWork cross-functionallySolve problems
Bachelor’s Degree in Chemical Engineering from Istanbul University in 1993
Training and Certification
Pharmaceutical Technology Certification
Six Sigma Green Belt Certification