Quality Assurance Supplier Manager
AstraZeneca Mölndal / Kemistjobb / Mölndal
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hela Sverige AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world?s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
The Arena
The incumbent works closely with GES QA Directors and Senior QA Supplier Managers to support the performance of required QA System activities for GES. They are responsible for QA activities that support execution of Quality Management of Suppliers within GES. This includes the Quality System performance of the following activities: change control, product quality complaint and deviation investigations, quality issue management and escalation, QA Agreements (establishment and maintenance) between AZ and External Suppliers and between GES and AZ Operations Sites and QP certification of product on the GES Sweden License. In addition, the preparation and submission of periodic Supplier Quality Assessments and performance of Regulatory Agency interactions as needed. Regulatory Agency interaction includes assisting in the preparation for and management of Regulatory Agency inspections at External Suppliers and AZ Sites (when external suppliers are within the inspection?s scope), license updates and notification of product issues.
The Role
• Certification of product on the GES Sweden license
• Batch record reviews (including certificates of conformance/analysis, assessment of deviations as required) and batch release including working in relevant quality management systems (QIMS, ICON, etc).
• Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to GES/AZ site leaders
• Collaborates in data analysis and report creation on quality metrics and key performance indicators
• Serve as Business Process Owner(s)of the following systems:
• Deviation Management System
• Global Complaint Management System
• VA & C database
• Product Quality Review
• Quality Assurance Agreement
• Approval of data into associated systems, including stability data received from Supplier or AZ laboratories
• Collaborates within GES / GESQA to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
• Supports GES Quality Management Systems:
• Maintains quality data and records in relevant quality management support systems (e.g. GCM, OCM, Trackwise, etc) as required.
• Assists in the production of, or contribution to, AZ quality documentation (including GES SOPs, Q & C Manual Procedures, etc)
• Participates in GES self-inspection program, auditing processes and procedures.
Preferred experience
• Multi-site / multi-functional experience
• Proven experience in Quality Assurance or combination of Quality and Technical.
Internal Contacts
• Regional team members
• Category/sub Category Team members
• QA and other support groups within or across sites
• Integrated Supply Chain (PSCT)
• Regulatory Affairs (including GQO CMC RC)
• GQO
• Global Supply Managers/Directors.
More information
Please contact: Adam Mclennan, at +44 1625 513217.
Welcome with your application via
www.astrazeneca.se .
Varaktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2015-08-24ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2015-09-04
Ange följande referens när du ansöker: MOL000001VG
FöretagAstraZeneca Mölndal
AdressAstraZeneca Mölndal
43183 MÖLNDAL
KontorsadressPEPPAREDSLEDEN 1
MÖLNDAL
Övriga kontaktuppgifterTelefonnummer: 031-7761000
Jobbnummer 2402169
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