CSV Validation LeadValidation support for Complaint Handling SystemValidation support for Image Guided Therapy systemsQuality Assurance CSV role for SAP kernelsQuality Assurance CSV role for IT, production, lab systems (tickets, changes, CAPA, events, tickets, document review, periodic review). Quality oversight in specific projects (Monitoring system, DCS system, automation network, serialization and aggregation solution for pharmaceutical products, custom build artwork… Show more CSV Validation LeadValidation support for Complaint Handling SystemValidation support for Image Guided Therapy systemsQuality Assurance CSV role for SAP kernelsQuality Assurance CSV role for IT, production, lab systems (tickets, changes, CAPA, events, tickets, document review, periodic review). Quality oversight in specific projects (Monitoring system, DCS system, automation network, serialization and aggregation solution for pharmaceutical products, custom build artwork management software, tools for creation and approval of artwork for pharmaceutical packaging materials, e-platform for clinical trials).Validation support for a legacy SAP systemDeveloped a training for Data IntegrityExecuted data integrity assessments and -remediation.CSV QA support for an automation network.CSV QA support for a serialization and aggregation solution for pharmaceutical productsValidation of critical tools used for the creation and approval of artwork for pharmaceutical packaging materials.Validation of a radio pharmacy software.Validation of an iTLC Scanner and software.Validation of desktop virtualization and IT infrastructure qualification for GMP critical applications .Validation of a custom build automated release control system.Validation of Excel workbooks.CSV QA support for an innovating e-platform for clinical trials.CSV QA support for a custom build artwork management software.Developed a Master Plan for legacy computerized systems.Developed a generic EU Annex 11 compliance specification.Support with a country wide validation framework for a hospital pharmacy software in the Netherlands and validated systems in hospital pharmacies. Show less

Periodic review of computerized systemsQA CSV support for a custom build artwork management systemSupport the customer with an approach for validating Excel workbooks.Development of generic user requirements for automated systems to comply with GLP principles and 21 CFR Part 11.Validation support for a medication distribution system (Geneesmiddel Distributie Systeem - GDS)Validation support for changes to a custom build laboratory instrument control and data management… Show more Periodic review of computerized systemsQA CSV support for a custom build artwork management systemSupport the customer with an approach for validating Excel workbooks.Development of generic user requirements for automated systems to comply with GLP principles and 21 CFR Part 11.Validation support for a medication distribution system (Geneesmiddel Distributie Systeem - GDS)Validation support for changes to a custom build laboratory instrument control and data management software.Support different customers with the validation of hospital pharmacy manufacturing systems.Support the customer with the validation of an iTLC scanner and software.Support the customer with the validation of software modules for a colony counter.Overall operational responsibility for the Compliance & Validation Services department within Rescop BVBA. Show less

Support the customer with the development of validation templates for validation of Excel workbooks.Validation support for a medication distribution system (Geneesmiddel Distributie Systeem - GDS)Validation support for changes to a custom build laboratory instrument control and data management software.Executed periodic reviews on systems identified by the customer.Supported the customer with project management, implementation and validation support of desktop virtualization and… Show more Support the customer with the development of validation templates for validation of Excel workbooks.Validation support for a medication distribution system (Geneesmiddel Distributie Systeem - GDS)Validation support for changes to a custom build laboratory instrument control and data management software.Executed periodic reviews on systems identified by the customer.Supported the customer with project management, implementation and validation support of desktop virtualization and IT infrastructure qualification for GMP critical applications.Supported the customer with decommissioning of systems.Project management and validation engineering for a radio pharmacy software to be implemented and validated at customers site.Performed an assessment on the quality system and computerised system validation practices at a hospital pharmacy.Supported customers with the validation of different central filling systems.Supported the customer with the validation of a clinical electronic data management system.Support different customers with the validation of hospital pharmacy manufacturing systems (PROAZ II, III, BAPS, IBC).Supported the customer with the validation of the integration of the G-standard into a hospital management system.Support the customer with the evaluation requirements for a VTGM (Voor Toediening GereedMaken) software.Support the customer with the validation of a radiopharmacy manufacturing software.Supported the customer with the validation of a warehouse "orderpicking barcode system".Provided overall Quality Assurance support in projects identified by the client:* provide support with the resolution and follow-up of FDA Form 483 observations* provide support with the Prior Approval Supplement submission of a drug product* provide QA overview in projects dealing with equipment, utility and facility qualification and automation validation.Overall operational responsibility for the consultancy department within Rescop BV. Show less

Provide overall Quality Assurance support in projects identified by the client:* provide support with the resolution and follow-up of FDA Form 483 observations* provide support with the Prior Approval Supplement submission of a drug product* provide QA overview in projects dealing with equipment, utility and facility qualification and automation validationSupported the client with the migration to Windows XP for laboratory software.Supported the client with the 21… Show more Provide overall Quality Assurance support in projects identified by the client:* provide support with the resolution and follow-up of FDA Form 483 observations* provide support with the Prior Approval Supplement submission of a drug product* provide QA overview in projects dealing with equipment, utility and facility qualification and automation validationSupported the client with the migration to Windows XP for laboratory software.Supported the client with the 21 CFR Part 11 compliance assessment and validation of a building access control system.Supported the client with prospective validation of the QM and PP-PI modules of SAP ECC 6.Finished a project to analyze the software development and -validation gaps against GAMP 4, to remediate the software and to improve the overall Quality System. Show less

General Management of the company, including operational, financial, human resource and sales&marketing management.Performed quality control reviews on validation documentationDeveloped Qualification Master Plan for laboratory system Supported client with internal and external inspectionsSupported client with the development of a validation methodology and –templates for laboratory systemsValidation of computerized laboratory systemsValidation of Chromatographic Data… Show more General Management of the company, including operational, financial, human resource and sales&marketing management.Performed quality control reviews on validation documentationDeveloped Qualification Master Plan for laboratory system Supported client with internal and external inspectionsSupported client with the development of a validation methodology and –templates for laboratory systemsValidation of computerized laboratory systemsValidation of Chromatographic Data SystemsAnalytical and computer remediation for legacy automated laboratory systemsTraining on Laboratory System ValidationTraining on Computerized System ValidationProject ManagerSpeaker at conference Show less

Interpretation of validation and part 11 regulatory requirements and recommended practicesParticipating member in validation projectsDevelop/update laboratory system validation methodology to be used on all sitesSupport and train the staff in their specific roles and responsibilitiesManage consultant teams on all sitesQuality review of validation documentsFacilitate the approval of validation documentsProject Manager for Part 11 assessments and – remediation… Show more Interpretation of validation and part 11 regulatory requirements and recommended practicesParticipating member in validation projectsDevelop/update laboratory system validation methodology to be used on all sitesSupport and train the staff in their specific roles and responsibilitiesManage consultant teams on all sitesQuality review of validation documentsFacilitate the approval of validation documentsProject Manager for Part 11 assessments and – remediation Global Solution Team Leader for Part 11 remediation Participating member within the global Computerized System Validation Methodology ProjectSupport in GMP, GLP and Part 11 issuesMaintain a liaison with other industrial work groups and societies, e.g. ISPE.Project manager for specific validation projects Show less

Coordinate and execute validation activities for laboratory systems within the departmentAdvise the validation teamsResponsible for the Validation Master Plan of the departmentParticipating member within the Computerized System Validation Methodology ProjectParticipating member within the Laboratory System Validation Methodology Project Project manager for specific validation projects

Responsible for the general IT infrastructure within the departmentFirst line support to end users for IT related issuesServer administrator for departmental dataIT solution development for gas chromatographic applications

Introducing capillary gas chromatographyMethod development and –validation of gas chromatographic methods for drug substancesResponsible for specific solutions requiring gas chromatography Determination of acids in gastric juice Determination of volatile compounds in environmental air Determination of volatile organic compounds in drug substancesGLP and GMP environment