The QA manager is given the responsibility of management representative at the facility level. The management representative has the responsibility to :
· Maintain compliance to the requirements established in the quality management system
· Periodically evaluate the Quality system performance, identify areas that need improvement and report to senior management
· Develop the company culture and the management approach by supporting and sharing the Sterigenics Quality Policy.
· Ensure that the Quality Policy is communicated and understood within the facility
· Lead projects and programs to achieve and improve facility targets and objectives.
· Ensure the promotion of awareness of customer and regulatory requirements throughout the organization.
· Ensure that processes needed for the business unit and local quality management system are established, implemented, maintained and improved.
· Ensure the required systems are operative and effective to assure customers of the desired quality
· Implement continual improvement attitude
· Facilitate quality improvement tools
· Review the facility quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness
· Maintain the contacts with supplier/customer (visits, meetings, complaint handling, audits, …)
· Represent the company in quality matters
· Coordinate and perform site assessments
· Coordinate customer audits and regulatory audits/inspections (AFMPS, FDA, BSI, AFSCA)
· Coach, train, manage and develop the quality control/assurance department
· Participate at Corporate QA-meetings
· Provide to food regulatory agencies the quarterly listing of irradiated food products
· Assure proper functioning of QC Team
· Assure good coordination of process QC activities
· Assure adequate training level of the team
Knowledge/Education and Training:
· Master in Life Sciences (Biology, Chemistry…)
· Relevant experience in Quality Assurance (at least 5 years)
· Relevant experience in management function (at least 3 years)
· Experience in the pharmaceutical medical device industry is an advantage.
· Fluent in English (reading, speaking, writing).
· Fine organizational skills
· Excellent communication skills on all levels
· Efficient, accurate, work according to plan
· Problem solving attitude
· People manager
· High profile commitment to quality
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