Oversee quality assurance for two sites - Netherlands and UK.In charge of site certifications-ISO 9001, AS9120, ISO 14001, ISO45001, ISO17025, AS 6180, AS 6171, ESD S20.20Resolve customer corrective actions through completion.Perform internal audits on all standards listed above.Drive continuous improvements Qualify vendors and manage supplier quality

Managed product quality and compliance for both Karsten International sites.Checked product quality and functionality on pre production and mass production samples from the factory. Highlighted non conformances and worked on improvement plans.Approved artwork, packaging and rating labels on all productsManaged the regulatory certificates for all products( CE, REACH, PIF and other regulatory requirements) Managed a team of 2 individuals( Assistant QA manager and QA specialist) Managed BRC broker certificate compliance by conducting internal audits and facilitating external auditsWorked with customers and vendors on product quality related issues.

• Managed all quality, regulatory and returns activities in the company.• Reduced product returns by €120,000 in 6 months. Reduced quality related defects by 30%.• Created process flows and work instructions for several departments. Facilitated value stream maps and improved the order entry and review process but eliminating non value added steps.• Managed the Corrective action process and improved internal processes by issuing corrective actions. Improved supplier quality and customer responsiveness by ensuring timely closures of corrective actions.• Provided training to all EMEA team members on Lean, Six Sigma and 5S principles.• Managed the safety of the company by conducting regular safety audits and Gemba walks.• Reviewed and updated ISO-9000:2015 procedures, work instructions, inspection and test instructions. Worked with all EMEA countries and departments and facilitated in both internal and external ISO 9001:2015 audits• Improved the ERP product database quality by 30% by collecting and populating critical product related information from the vendors.• Participated in the supplier score card and Quarterly business review program with the suppliers on Quality, on time delivery, pricing and responsiveness.• Managed the creation of CE, ROHS, REACH and other regulatory requirements for the company

• Implemented Lean labs principles in Pharmaceutical Quality control labs across two sites in India and China.• Averaged 35% productivity improvement per project • Reduce lead time and throughput time by 25-40% by facilitating flow• Increased Right First Time by 15% using standard work principles.• Improve communication through Visual Management and huddle meetings• Facilitated culture change through education, empowering people, and removing roadblocks • Trained team members and provided workshops in Lean principles across both the locations(India and China)BSM is the global leader in the provision of Real Lean Transformation services to Life Science companies. We specialize in implementing Real Lean in QC Laboratories, QA-related processes and R&D departments'. We are currently supporting global Lean programs in 4 of the world’s Top 6 pharmaceutical companies. We operate from offices in Galway, Ireland, North Carolina, USA and India. All of our consultants are outstanding individuals, universally recognised for their expertise, professionalism and ability to achieve results.Clients seek help from BSM when their businesses need step changes in performance on a scale which generic Lean/Sigma techniques cannot deliver. We specialise in the implementation of ‘Real Lean’ techniques, specifically Levelling, Flow and Standard Work, which often receive insufficient attention in Operational Excellence programs.

Managed the Material Return Request (MRR) process to ensure accurate and timely disposition of nonconforming materials.Successfully worked with suppliers on product enhancements to improve overall quality and reduce waste/defects and scrap.Established leader with the safety committee as proven by developing a worker safety program that can be certified to OSHA 18001. Well versed with internal and external ISO auditing and maintaining ISO proceduresDeveloped a Lean Six Sigma training program and provided training for 3 individuals with successful completion of 3 green belt projects. Reduced shipping customer’s complaints by 15%, increased department OTD by 6% and reduced BOM errors by 15%.Managed the corrective action and customer complaint process and assisted recipients in identifying root cause of problems, establish action plans and follow up on effectiveness. Participated in supplier reviews and provided inputs to the materials group regarding supplier performance.Conducted on site audits for both new and existing suppliers to assess capability and to promote continuous improvement.Reduced defects by 9% and increased overall throughput by 11% in 3 manufacturing departments.Used Project management principles and MS project to plan, schedule and execute all stages of ERP software implementation project. Assessed business implications for each project phase and monitored progress to meet deadlines, standards and cost targets.Worked with sales and conducted a value stream map to streamline the pricing procedure. Identified areas for improvement and helped in conducting a SWOT analysis to determine the health of our products.Participated in risk management meetings and developed contingency plans on risks associated with materials and manufacturing.

Worked with R&D to find primary and secondary sources of supply for all purchased components for the new heater. Resolved technical issues between the vendor, production and engineering.Sourced and purchased special items needed for production or R&D projectsUsed six sigma methodologies to analyze and reduce scrap in the plant .Negotiated with vendors and suppliers the best possible price for materials Identify target suppliers, establish expectations, action plans and results to deliver required improvements and sustainabilitySolved make vs. buy decisions based on issues we were having on partsResponsible for overseeing the integrity of the inventory data and vendor files Worked with the Materials Group on supplier evaluations and improved noncomplianceWorked with the product standardization team and created work instructions and standardized work in every departmentsEstablished a strategic pricing program Act as key contact when outsourcing manufacturing work

Created manufacturing standards plant wide for all departments by performing time studies and conducting workshops Analyzed current routing information in MFG PRO and modified them to reflect accurate shop floor data in order to cost our products more effectively.Worked with finance and performed a product portfolio assessment which highlighted products which are complex to manufacture and yeild low profitsManaged technology transfer projects by coordinating efforts with other departments during the entire transfer process. Lead project teams in defining process measurements and continuous improvement initiatives.Identify the flow, process capabilities and production standards and costs involved in manufacturing processes.Conduct and analyze time studies for production processes related to transferred products from the PPD lab to production.Schedule Attainment - Worked with Manufacturing and created master schedules for time constraint products in order to reduce deviations and increase efficiency.Worked with Department heads and helped in creating an Operation Strategy for Phase VWorked with Manufacturing and Finance and identified opportunities for improvement in capturing Labor hrs (direct vs. indirect), Material Usage and accordingly created short term and long term plans to implement these ideas.Worked with Manufacturing and Product development and analyzed Quality and manufacturing data and accordingly made suggestions to possibly increase the manufacturing hold times and batch sizes on select products.Helped in writing SOP’s for Phase V equipment by the IOQ Execution due date.Created Waste flow and in- process/final product sample flows for all Production and Quality areas in phase V.Conducted a feasibility study for the use of disposables in Formulations and Filling areas.Created Business process Maps Using ARIS for “As is “and “To be” process within contract manufacturing, PPD and Tech Transfer.

Conducted analysis of manufacturing data and was heavily involved in purchasing packaging machinery .Managed a cross functional eam and coordinated scheduling, validations and maintenance activities. Prepared SOP’s and was involved with complex problem solving on the machine.New Phase Planning- Created a detailed plan by Developing Metrics, Identifying products and creating floor and line layouts to maximize floor space and equipment utilization for the new buildingAudited and managed the departments management operating system which illustrated key areas such as productivity, line efficiency, overtime control, earned hours, resource load and accordingly came up with a list of action plans.Designed an MS access database which stores all production and downtime information. Created Production reports and Pareto charts and reduced downtime on the lines by 20%.Eliminated waste on the packaging lines by using 5S and lean principles.