• Ensure effective operational implementation of the QMS across all GxP areas
• Ensure appropriate functional QMS elements are in place and described in the local Quality Manual/Standard Operating Procedures
• Ensure GxP compliance is visible to CP and Area by active liaison with GxP Quality Leads
• Report GxP compliance status to CP and Local Leadership Team through the MC Management Review meeting and assure that gaps are addressed appropriately in order to mitigate risk
• Ensuring the GxP area(s) under respective Quality unit responsibility are run in accordance with external regulations
• Ensuring appropriate levels of resource to complete GCP, GVP, GRP or GMP/GDP activities appropriately
• Together with Local Leadership members, ensure conduct of adequate training at the MC in the related GxP activities by defining, planning and supporting training activities. Ensuring GxP self-assessments in the corresponding GxP area
• Manage external inspections, complaints, deviations, recalls, counterfeits and product tampering according to the AstraZeneca Quality Policies and Standards. Ensure relevant CAPAs have been completed / closed
• Establishing improvement priorities
• Ensure quality oversight of third party and coordinate all required activities to guarantee that third party (re-)packaging, (re-)labelling, storage and/or distribution of AstraZeneca products is in compliance with AstraZeneca Standards.
• Establishing and maintaining business continuity plans in the corresponding GxP area

Date Posted

11-thg 3-2020

Closing Date

29-thg 4-2020

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.