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Head of QA/QC


Sophie Steels
Recruiter
+32 496 49 18 21


Job description

For a company  focused on Extracellular Vesicles, Exosomes research and drug development, we are looking for a senior Head of QC/QA

Responsibilities:

Quality Management System:

• Implementation and management of ISO and GMP principles according to international and national Belgian law and regulations

• Monitor development and validation of the quality control testing

• To approve specifications, sampling instructions, test methods and other Quality Control procedures

• To ensure that the appropriate validations are done

Compliance:

• Acknowledgement and maintenance of the QMS system, including but not limited to Deviations, Corrective actions and Preventive actions; entrance rules and waste disposal; training rules; health and safety problems

• Ensuring to be up to date as concerning the applicable Directives, guidelines, standards and applicable laws is concerned

• To approve or reject, as she/he sees fit, starting materials, packaging materials, intermediate, bulk and finished products

• To ensure that all necessary testing is carried out and the associated records evaluated

• Maintain copies of all approved study plans and standard operating procedures in use in the test facility and have access to an     up-to-date copy of the master schedule

• Verify that the study plan contains the information required for compliance with these principles of good laboratory practice

This verification should be documented

• Prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including

the phase(s) of the study inspected, and the dates inspection results were reported to management and the study director and

principal investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.

Audit Program:

• Organize internal audits and external audits and inspections

• Conduct inspections to determine if all studies are conducted in accordance with these principles of good laboratory practice Inspections should also determine that study plans and standard operating procedures have been made available to study personnel and are being followed. Inspections of the Test sites might require travels

• Inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies

Training:

• Ensuring that she/he participates in regular and continuing education and professional development programs and in particular when procedures change, or scientific knowledge develops

• To ensure that the required initial and continuing training of her/his department personnel is carried out and adapted according to need


Profile

Education: Bachelors or Master  preferred or any other certifications related to the Quality systems

Employment


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