QA Document Controller
Since April 2013
biopharmaceutical company specialized in innovative ophthalmic medicines
- implementation, development and management of a learning management system (lms) within the company.
- define and write user requirements for a lms system, qms system and SOP system.
- ensure GXP Training globally, upload all GXP procedures on the lms system and allocate trainees according to Training matrix.
- Training management/ coordination of Training matrix.
- provide Technical Support related to capa’s, deviations, Change Control.
- management of SOP system/controlled documents
- follow up on deviations, change controls, capa’s, audit findings, review of procedures, methods and specifications.
- prepare, monitor and follow up of the GXP related kpi’s.
- review and give qa release to all controlled documents.
- contribution to successful completion of inspections from fagg and FDA.
Biopharmaceutical Company specialized in innovative ophthalmic medicines
- Implementation, development and management of a Learning Management System (LMS) within the company.
- Define and write user requirements for a LMS system, QMS system and SOP system.
- Ensure GxP training globally, upload all GxP procedures on the LMS system and allocate trainees according to Training Matrix.
- Training management/ Coordination of training matrix.
- Provide technical support related to CAPA’s, Deviations, Change Control.
- Management of SOP System/Controlled Documents
- Follow up on deviations, change controls, CAPA’s, audit findings, review of procedures, methods and specifications.
- Prepare, monitor and follow up of the GxP related KPI’s.
- Review and give QA Release to all Controlled Documents.
- Contribution to successful completion of inspections from FAGG and FDA.
QA Warehouse Coordinator Mons Saint Guibert and MelselseMarch 2012 --- April 2013
Medical Devices company specialized in blood transfusion technology
- follow-up of corporate holds and recalls in different emea warehouses.
- inspect returned goods and decide on the next steps in Compliance with company quality standards.
- follow up and investigate complaints related to warehousing and distribution. implement corrective and preventive actions (capa).
- follow up non-conformity and capa related to the warehouse and distribution activities.
- implement and review sops in all emea subcontracted warehouses.
- create and update procedures and work instructions for the warehouse activities. procedure Owner and subject matter Expert.
- ensure Compliance of subcontracted warehouses related to labeling, inventory discrepancies and status management.
- implement corrective actions on expiry date discrepancies.
- coordination of value added processes: repackaging process, over-labeling process and scrapping process.
- complaint and deviation management follow-up suppliers in case of complaints or deviation related to their products or services.
- prepare, monitor and follow up of the warehouse kpi’s.
Warehouse Supervisor Leuven, BelgiëOctober 2007 --- March 2012
- implementation of new warehouse in belgium, leuven and netherlands, geleen.
- manage transfer of activities from belgium, leuven to the netherlands, geleen.
- supported lifecycle activities from Clinical Trial till commercial launch of chondrocelect ®
- managed GMP/gdp implementation in warehouses.
- organisation and co-ordination of warehouse tasks: inventory control, purchase of goods, status management, interaction with suppliers and service providers, preparation of release Documentation for purchased goods, organization of supply towards the culture Lab and quality Lab, temperature mapping, follow up pest control plan.
- Document Management. holding up to date of material specifications, standard operation procedures (SOP’s), work instructions and forms used in the warehouse.
- coordination of Logistics flows and return flows of the biopsies and cultured chondrocytes to and from the Hospitals.
- supplier management with Negotiation of yearly agreements with focus on cost optimization.
- experience in Aseptic Operations. viable and non-viable monitoring, sterilisation of equipment and Disposables, media preparation.
- support in several studies of chondrocytes.
- process Validation, qc for several studies.
- contribution to successful completion of two GMP inspections.
Area / Region