・ Monitor and support the achievement of the Global Quality Objectives & Targets;
・ Ensure the adherence to the global corrective and preventive action standards as well as being actively involved in the root cause analysis and agreement of corrective and
preventive actions for severe and reoccurring incidents, audit findings, KPI deviations etc.;
・ Support countries in the AR during external audits against ISO 9001;
・ Support the implementation of the global incident handling standards within the AR;
・ Perform tasks as QHSE responsible in CAPA process
・ Support Products in regards to continuous improvement initiatives using tools like Lean Six Sigma or others;
・ Ensure that the countries are aware of and can use the IMS. Where necessary, organize and execute training material available
・ Drive BCP walkthroughs in the AR
・ Support the implementation of the key quality industry certifications (e.g. SQAS);
・ Support on tenders and customer audits in regards to quality requirements in the AR;
・ Perform internal QHSE audits and QHSE subcontractor audits according to the regional audit plan
・ Participate in external QHSE or related audits according to the regional audit plan.
・ Ensure that a Quality Management System is implemented and maintained based on:
・ Company GDP Standards, applicable GDP guidelines (WHO/EU/FDA) and local regulations.
・ Signed Customer Service Level Agreements.
・ Support the Business Unit in appointing a qualified and trained BU GDP Responsible Person(RP).
・ Evaluate regulatory changes potentially impacting Company GDP activities and communicate them to the BU GDP RPs;
・ Support the Business Unit in the certification process and Company´s GDP certification strategy;
・ Ensure that the GDP relevant subcontracted activities and suppliers are approved, Quality Agreements are signed and Audits/Assessments are carried out in cooperation with the product;