For one of our clients, we are looking for a Head of QC/ QA with demonstrated experience within the pharma sector and preferably within cell therapy or stem cell research.
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;
* Organize on a regular base a Quality Management System review meeting;
* To ensure the qualification and maintenance of her/his department, premises and equipment;
* To ensure that the appropriate validations are done; * Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management;
* 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;
* 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;
* Promptly report any inspection results in writing to management and to the study director, and to the principal investigator(s) and the respective management, when applicable;
* 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;
Other responsibilities that might be shared with the Production Manager:
* Monitoring and control of the manufacturing environment;
* Process validation;
* Authorization of written procedures and other documents, including amendments;
* Production site hygiene;
* Approval and monitoring of suppliers of materials;
* Approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities;
* Designation and monitoring of storage conditions for materials and products;
Other QMS and related regulatory work:
* Communicate with the regulatory authorities;
* Application and maintenance of GMP license for EV drug manufacturing;
* Tech Transfer Communication to CDMO's.
* 5 years of experience in QC/QA in the pharmaceutical sector, and preferably within cell therapy or stem cell research;
* Bachelor is preferred or any other certifications related to the Quality systems;
* Problem solving skills;
* Good communication and managerial skills;
* Work under time pressure;
* Very good English;
Interested? Do not hesitate to send us your CV!
Regarding this role, Kelly Services acts as the official mediator. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement.
In keeping with the Law regarding discrimination and equal opportunity in Belgium, Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.
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