Jan Hanskamp Email & Phone Number

Canada

Canada

o Conduct audits at clinical sites worldwide (USA, Canada, Argentina, Brazil, Italy, Republic of Korea, Taiwan, Hungary)o Involved in clinical trial activities (e.g., QA and GCP support to operational teams, development/review of trial-specific documentation, etc.)o Conduct internal auditso Act as CAPA manager, overseeing the CAPA processo Assist in developing the Quality Management System (QMS)o Create and update procedureso Assist in hosting Sponsor audits and… Show more o Conduct audits at clinical sites worldwide (USA, Canada, Argentina, Brazil, Italy, Republic of Korea, Taiwan, Hungary)o Involved in clinical trial activities (e.g., QA and GCP support to operational teams, development/review of trial-specific documentation, etc.)o Conduct internal auditso Act as CAPA manager, overseeing the CAPA processo Assist in developing the Quality Management System (QMS)o Create and update procedureso Assist in hosting Sponsor audits and inspectionso Assist in development and presentation of trainingso Perform QC of documentationo QA approver of CSV package documentso Maintain trackers used in QA department Show less

Montreal, Quebec, Canada

o Development and management of quality documentation, to include but not limited to, SOPs, training, and sponsor documentationo Hosting and supporting customer auditso Participates in regulatory inspectionso Performs audits (e.g., process, project, vendor, investigator site), as appropriateo Performs quality control review of regulatory documents as neededo Supports quality issue/deviation investigations, and CAPA managemento Lead the LMS space to actively support staff… Show more o Development and management of quality documentation, to include but not limited to, SOPs, training, and sponsor documentationo Hosting and supporting customer auditso Participates in regulatory inspectionso Performs audits (e.g., process, project, vendor, investigator site), as appropriateo Performs quality control review of regulatory documents as neededo Supports quality issue/deviation investigations, and CAPA managemento Lead the LMS space to actively support staff learning & development within the companyo Draft and contribute, as Subject Matter Expert (SME) in the field of Quality Officer, activities to the evaluation/improvement of processes and procedures within the Quality Management System (QMS)o Support with Quality Metricso Support with onboarding of new hires (welcome meeting, training assignments, etc.)o Support BD/Legal with client RFIs and questionnaireso Prepare monthly QA Newsletter to share with company Show less

o Independently perform inspections and audits to monitor processes, facilities, formulations, equipment, personnel, materials, supplies, methods, and practiceso Assure CRL’s compliance with GLPs and applicable federal, state, and local regulations o Perform data audits to ensure that records are ALCOA and in compliance with regulations, international standards, SOPs, and protocolso Review SOPs, protocols, reports, and other quality and regulated records for accuracy, completeness… Show more o Independently perform inspections and audits to monitor processes, facilities, formulations, equipment, personnel, materials, supplies, methods, and practiceso Assure CRL’s compliance with GLPs and applicable federal, state, and local regulations o Perform data audits to ensure that records are ALCOA and in compliance with regulations, international standards, SOPs, and protocolso Review SOPs, protocols, reports, and other quality and regulated records for accuracy, completeness, and complianceo Coordinate with all levels of personnel (study directors, scientists, technicians, etc.) to ensure audit findings are addressedo Maintain written and signed records of all audits and inspectionso Participate in department meetingso Participate in the preparation/review of study and QA files for sponsor visitso Identify, document, and report deviations from regulations, protocols, or SOPs Show less

Montreal, Canada Area

o DNA extractiono Radioimmunoassayo Hybridizationo ELISAo Mincing/homogenizationo UV Spectroscopyo Data Reviewo R&D

B.Sc., Biology

Cegep, Health Sciences

High School