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Sr. Consultant QA/QC

Work Experience

2005: Sr. Consultant,
- Advice in validation of cooling systems for international In Vitro Diagnostics company
- Internal auditing and re-engineering of Quality Management System in Dutch Medical Device Company.

1999 - 2004 IsoTis Bilthoven
Manager Quality Control (2001 ¡V 2004)
„X Established a testing and inspection (QC) system and department, in accordance with cGMP and EC GMP- GCLP, which is both quality driven and cost efficient
„X Ensured timely delivery of reviewed and approved test results, according to QC planning, for both in house and external QC testing
„X Performed Quality internal and audits
„X Contributed to test development by advising with regard to sampling plans, reference materials, method validation, SPC, SOPs , ensuring testing according to set specifications, compliance with GMP and smooth transfer of methods from development to QC
„X Ensured efficient equipment planning, qualification and maintenance and calibration
„X Created a system to ensure sufficient availability of (raw) data, both paper and electronic
„X Ensured skilled staff by optimal organisation and staffing of the QC department.
„X Set up of a well organised Out Of Specification (OOS) System.

Quality Assurance Engineer (1999 ¡V 2001)
„X Project Management: Developed Design Control Procedures and Tools, developed training, trained employees
„X Started a Method Validation program (QC-tests), method validation training and personal coaching
„X Started up Statistical Methods and training, and ensured training in applicable software
„X Organised GMP training by designing checklists, procedures, and trained employees ¡¨on the job¡¨, selected and purchased training programs
„X Performed Internal Quality Audits, and GMP inspections
„X Participated in Project teams, advised and coached project teams
„X Created several quality system improvements (Shelf Life Stability Testing, Production Documentation, etc.) meeting ISO 9001 and FDA QSR requirements

1993 - 1999 Organon Teknika (Akzo Nobel) Boxtel
Quality Engineer (1998 ¡V 1999)
„X Project Management: co-ordination of biomaterial project, co-ordination of sub-projects (e.g. process risk analysis, shelf life stability)
„X Project Management: supported product development team members i.e. validation aspects
„X Created a quality system for the Biomaterial Development & Production department, meeting ISO 9001 and FDA requirements
„X Trained, advised and coached colleagues at quality aspects
„X Created tools (checklists, flow schemes, templates) to improve integration of quality within the department/ project teams
„X Designed, executed and reported risk analysis for biomaterials i.e. monoclonal antibodies, polyclonal antibodies, recombinant proteins

1st Assistant Quality Engineer (1996 ¡V 1998)
„X Planned, executed and reported activities related to assurance of quality in all biomaterial production process steps (quality by design) during product development
„X Assuring the required and constant quality by connecting and retrieving input from R&D, Operations, Regulatory Affairs, Logistics, Purchasing departments
„X Designed, described and documented specifications of starting materials, test procedures, release requirements and procedures, manufacturing procedures
„X Improved the quality system of a Microbiology and Cell Culture department
„X Supported activities related to structural changes in production processes (replacement of critical starting materials, replacement of release procedures, validation etc.)
„X Project Management: participated in approximately 20 different projects (project team member)

1st Laboratory Assistant A, chief of laboratory (1993-1996)
„X Developed Micro Elisa assays for detection of HIV antibodies and for HCV antibodies, including conjugation, blotting, coating, purification freeze-drying techniques
„X Attended students
„X Trained colleagues in biosafety aspects (acting as Biosafety Assistant)
„X Controlled laboratory areas for meeting GLP regulations, supervised colleagues (acting as chief laboratory)
„X Controlled use, service and calibration of laboratory apparatus

1991 - 1993 University of Amsterdam Amsterdam
Research Technician Cell Biology and Histology
„X Studied the role of lymphocyte surface antigens in the immune system, and reported results
„X Isolated and cultured lymphocyte cells, producing monoclonal antibodies
„X Performed radioactive assays, FACS analysis, cell culture, cell fusions, ELISA¡¦s

1990 - 1991 Geveke Werktuigbouw BV Amsterdam
Sales Engineer
„X Purchased, quoted and sold aeration apparatus to chemical industries and sewage purifying plants
„X Advised and informed clients on technical aspects

1987 - 1990 Netherlands Cancer Institute Amsterdam
Biochemical Technician
„X Studied and reported the role of adhesion molecules in liver metastasis
„X Performed biochemical/cell biological techniques i.e. cell and tissue culture, cell transfections, protein characterisation and separation, SDS-page, blotting, immune precipitations, FACS-analysis and Histochemical techniques
„X Performed animal experimentation techniques
„X Attended students

Education

„X Certified Quality Engineer by American Society for Quality, ISBW, Houten, December 1999
„X Post HBO Immunology, Hoge School van Amsterdam, CLB 1992-1993
„X HBO-HLO Biochemistry (Bachelors degree), Ir. W. van den Broek Institute (HVA), Amsterdam, 1983 ¡V 1987
„X VWO, Keizer Karel College, Amstelveen, 1977-1983

Languages

Dutch, english, french, german, spanish (basic)

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