2021 - 2022: global LIMS system and site-specific requirementsRole: Global Project Manager
Customer: Merck KGaA HealthCare
Tasks:Global LIMS Team ? LIMS Work Package Owners (9 FTE)/ Local LIMS Teams ? BioTech & Pharma Sites (60 FTE)
- Act as Project Manager for the Global LIMS system of Merck Healthcare Quality (HCQ) based on the LIMS LabVantage platform.
- Interim Change Manager for Global LIMS System and Local site demand.
- Coordinate & prioritize project activities.
- Global HCQ task monitoring and tracking.
- Site task monitoring and tracking.
- Creation of project status report.
- Owner Weekly project status meeting.
- Close alignment with IT Project Manager & Site Owners.
- Preparation of monthly HCQ Site Status meeting.
- Initiate investigations for Root Cause Analyses and problem solving activities.
- Invoke LabVantage supplier project support for problem solving and new functionality.
- Monitoring, tracking & resolving deviations / CAPAs in the QMS.
- Managing Changes (tracking, monitoring and reporting) from submission, via assessments to approvals and finally preparing for Releases.
- CAB Advisory board membership for decision making process.
2016 - 2020: Maintaining connections between professionals across all disciplinesRole: QA Officer
Customer: MSD - Merck Sharpe & Dohme
Tasks: Team R&D ? Life Science Scientists (190 FTE)/ Team R&D IT ? IT Engineering, Compliance and Validation (10 FTE)
- Key role in maintaining liaison between personnel from all disciplines, and provision of sound advice to all stakeholders.
- Responsible for Global Information System Verification process, to ensure Enterprise / Corporate IT Solutions are fit-for-use, fit-for-purpose and realize business value locally.
- Responsible for provision of critical Quality Assurance review of QMS related key documentation associated with the SDLC process, process equipment and building qualification in a Research and Development GxP (GLP) environment.
- Identify and improve the R&D Laboratory framework and process chain, from sample data to final study report deliverable.
- Data Integrity Risk Assessments in the integral R&D Laboratory process data flow.
- Project Management OECD Principles Computerized Systems Implementations.
- Gap Analysis Merck SDLC (policies, procedures, practices) and ?OECD Principles of GLP? #17 Computerised Systems (Risk Assessment, Data Integrity).
- Analytics of electronic data in GxP (GCP, GLP) R&D Business Process; Data Governance, Data Quality and Data Integrity, Risk Assessments (e.g. ALCOA+, GDMP, GRMP, CGMP) Data Lifecycle and Migrations as well as Improvement and Opportunity Discovery.
- Support and advice business owners and scientists in the Quality Management Systems.
- Project Management OECD17, assessment, advice, implement and track implementations.
- R&D IT process alignment and harmonizing on Global organizational level.
- Evaluation Regulatory Requirements (e.g. WHO, OECD, MHRA, FDA) and Industry Standards / Guidelines (e.g ISPE GAMP, ICH) in business context.
- Reviewing of SDLC validation and qualification documents related to computerized lab-equipment.
- GAP and operations assessments e.g. Supplier Quality Management (SQM) (Vendors, CROs, internal IT department).
- Review lab equipment document qualification deliverables IQ, OQ and PQ.
- Quality Assurance (e.g. approvals) lab equipment document qualification deliverables IQ, OQ and PQ.
- Lab equipment Supplier Auditing.
- Risk Assessment GxP (GMP, GLP, GCP) computerized lab-equipment, lab-platforms (e.g. Data Processing, LIMS), lab-informatics (e.g. ELN) evaluate and identify criticality.
- Hazard and Risk assessment (FMEA) computerized lab-instruments and lab-utilities.
- Evaluate non-computerized laboratory equipment and lab building qualification documents: URS, VP, DQ, FAT, SAT and (de-)commissioning.
- Review and approval Periodic System Reviews and User Reviews.
- Solving GLP inspection findings by SOP Improvements.
2014 - 2016: Developing a value propositionRole: Entrepreneur - (Innovation, Customer Validation)
Tasks:Target Audience - Innovative Entrepreneurs, Business Owners
- Developing online service to help others in reducing waste and increasing value that matters. www.valueaccelerate.com
- Lean Startup, Innovation and Business development.
- Developed a Value Proposition helping others to create value in products as well as services and to deliver it meaningful.
- Explore and develop Tools, Methods and Services to help innovative entrepreneurs.
- Research and study Value Leveraging.
- Perform Experiments, Customer Discovery and Customer Validation.
- Examine Customer Value and derive Meaningfulness and create Impact.
- Envisioning and developing Company Vision, Purpose, Values and Culture.
2009 - 2013: Ensuring validation activitiesRole: Validation Engineer, CSV Project Lead
Customer: MSD - Merck Sharpe & Dohme
Tasks:Project Teams - Manufacturing Applications (70 FTE)/ Team - SAP Developers (45 FTE)
- Supporting Developers and Project/Program Managers to ensure Project Validation activities (GMP, GAMP5, 21 CFR Part 11) and participate in delivering validated products being Critical Pharmaceutical Manufacturing Applications and a ERP (SAP) system for worldwide use.
- Coached in writing, reviewing and signing off Plans, Requirements, Designs, Test Specification, Testing and Delivering. This together with implementation good and effective Incident Handling of PR?s and CR?s.
- Provide periodic updates on progress and effort against established validation plans and statements of work.
- Responsible for Project and Program Management Validation critical Spreadsheet Applications.
- Provide Direction and Training to partners in CSV Operations (Global/Local CSV, Business, IT, Suppliers).
- Ensure Execution & Support of Validation Activities.
- Identify, propose and support CAPAs.
- Coordinate activities of Global CSV Change Officers related to Projects and Maintenance of Business. Review Validation Deliverables and Changes.
- Provide status reporting related to achievements, progress and concerns.
- Support Monitoring, Reporting and control of CSV Deviations.
- Maintaining Validation Master Plans (VMPs).
- Escalate Issues and Deviations to Ensure Global QA Awareness.
2007 - 2008: Optimization of the semiconductor development processRole: Improvement Officer, Coach Project Managers
Customer: NXP BU Automotive & Identification
Tasks:Team - Automotive & Identification (450 FTE developers in NL, DE and US)
- As Improvement Officer responsible for improvement of semi-conductor development process within BU Automotive department and reporting to Department Manager.
- R&D IT process alignment/ harmonizing on Global/ EU organizational level.
- Quality Improvement on BU Program Level was based on detecting weaknesses, opportunities, lessons learned and performing project milestone evaluations.
- Execute a pilot CMMi assessment with level 2 (L2) as reference. Wrote an overall Improvement Plan to get certified for L2 being in control by having repeatable project results.
- To realize he has formed an overall Project Process Improvement team and some temporary dedicated improvement KPA-teams to deploy the necessary improvements.
- Goals are accomplished and the results are recorded in the organization by looking at process way-of-working in combination with raising efficiency and being effective in executing the 10 development projects.
- Got recommended by corporate MT quoting ?record for fastest improvement? and L2 certified in Q1 2008 (score: 58% 2007/03 increased to 93% 2008/03).
2007 - 2008: Quality assurance and quality support in semiconductor developmentRole: Quality Assurance Officer, Project Reviewer
Customer: NXP BL Automotive Safety & Comfort
Tasks:Team - Semi-conductor developers in 3 project teams (30 FTE)
- As Quality Assurance Officer staff member of program office and responsible for Quality Assurance and Quality Support of Integrated Vehicle Networking semi-conductor development (CAN, LIN, Flexray) and reporting to Program Manager.
- Participated in development projects performing Compliance Verification, Milestone/Gate Audits and Measuring Confidence Level.
- Advising management team MT in the Project Review Board meetings.
- Decision making in Milestone/Gate passing meetings.
- Activities were focused on passing through the Product Creation Process by coaching the project managers and simultaneously profound emphasis on product quality.
- Decreased Iterations form 3 to 2 in First Time Right approach, reducing throughput time from 9 to 6 Months.
Earlier ExperiencesProvisioning of an OEM audio/video recorder moduleRole: Project Management Officer, Quality Officer
Customer: Philips Consumer Electronics, Advanced Systems and Application Laboratories
Tasks:- As Project Management Officer participated in a project (35 FTE) delivering an OEM Audio/Video Recorder Module including ?trick modes? based on encoding and decoding an audio/video signal to and from hard-disk. From analogue audio/video-signal to MPEG and backwards signal conversion.
- In the ASA-lab as a Quality Officer participated in the CoreTV-project (30 FTE) delivering generic component based re-usable software for TV-products. Member of the multi-disciplinary FTV-project (85 FTE) creating the Philips Flat TV.
Embedded System ProjectsRole: Managing Director, Business Owner
Customer: Guida Project Office
Tasks:IT Detachering and subcontracting Embedded Systems projects; feasibility studies, concept developments, (embedded-) software developments, test tools & equipment.
Software engineering expertiseRole: Software Team Lead, System Designer, Embedded Software Developer
Customer: NTS-group (former Te Strake)
Tasks:- Responsible for the software engineering competence and leading a small software engineering group. Selected and maintained relationships with subcontractors.
- Software responsible for embedded motion control systems used in mechatronic machinery based on series manufacturing. Typical industries; Textile, Graphical, Surface Mounting Manufacturing and Assembling Lines Robotics.
- Learned and practised in multi-disciplinary teams the power of creativity, integral concept design, synergy and holistic approaches to innovate effectively. Accomplished a.o. disruptive performance improvements in robotics.