QC Technician For an innovative hybrid Medical Device and Pharma company in Bilthoven, The Netherlands we are recruiting a QC Technician to join a dynamic and innovative team.
Position Overview Responsible for planning/coordinating testing and inspection activities related to company products, and recording, analysing and approving results during product development and manufacturing. Also responsible for environmental monitoring activities.
Responsibilities include, but are not limited to:
Coordination and planning of internal and external QC testing
Performance and reporting of inspection and testing of raw materials, production related materials and company products (intermediate and finished products).
Sampling of (raw) materials and products for inspection & testing.
Release of raw materials and production related materials.
Coordination, planning, performance and reporting of environmental monitoring (EM) of production areas and utilities.
Coordination, planning and testing of samples relating to shelf life and validation studies.
Calibration and maintenance of QC and EM related equipment, and maintenance of QC laboratory/areas.
Sampling of incoming (raw) materials, (final) products, shelf-life and validation samples
Plan, perform and report inspection & routine testing of incoming materials and products.
Release of incoming (raw) materials
Plan, perform and report testing in relation to shelf-life and validation studies
Communication with external test laboratories with regard to planning, execution and reporting of testing
Shipment of samples to external test laboratories
Inspection activities relating to product labelling
Implement and maintain QC databases, in order to ensure that relevant information is up to date and accessible to relevant functions.
Job Specific Duties – QA/QC/Regulatory
Write and/or review or approve quality control procedures and related documentation, including but not limited to specification documents and testing procedures.
Knowledge of relevant quality control requirements. Keep up-to-date on QC related topics and share information with colleagues.
Suggest possible improvements to current testing and identify needs for changes in the Quality Management System.
Minimum Education and/or Experience Required
HLO or equivalent.
Additional Experience and/or Qualifications
Knowledge of relevant quality systems and regulatory requirements
Must be able to work well independently, as well as being able to work cooperatively in a team of professionals.
Good working knowledge of ISO 13485 / ISO 9001 / cGMP (FDA 21CFR820- QSR) requirements and relevant technical experience relating to testing of medical devices or/and similar products.
Good English skills (written and spoken).
Accurate and pro-active.
Good interpersonal and communication skills are necessary.
Practicalities
Location: Bilthoven, The Netherlands
Start-date: ASAP
Permanent contract
Sound interesting? Please send your CV to Khanyi Mabena at k.mabena@panda-int.com or contract her on +31 2020 44502.