Quality Supplier Managers to AstraZeneca in Södertälje
Quality Supplier Managers to AstraZeneca in Södertälje
About AstraZenecaAstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and
Experis Engineering are currently looking for a driven and competent Quality Supplier Manager for AstraZeneca in Södertälje. Do you want to take your next career step witing life science at an exciting and reward-winning company? Let Experis Engineering open the doors to your dream job - send in your application as soon as possible!
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.
We are now seeking Quality Supplier Managers to join the Global Supplier Quality (GSQ) team.
The incumbent is responsible for the Quality management of assigned Quality system and compliance activities for GSQ supply chains and suppliers. They are responsible for all Quality activities that directly support execution of assigned Quality Management System elements. QSMs will be assigned in discussion with their line management, key areas of responsibility, but will be expected to learn other areas of the quality system to help support the rest of the team during times of peak workload or holiday coverage.
This includes, but is not limited to, the Quality System oversight and/or performance of the following activities:
Product quality complaint, Temperature Excursions or S&L complaint management, Deviation investigations, quality issue management and escalation, Product release (Career Level D required), Quality system element governance as either BPO or deputy BPO, Certification reports, Change control, SOP management, Stability Data entry and management, Supply Chain Assurance (SCA) system administration,Training System, Self-Inspection auditing, Quality Risk Management, Quality Agreements (establishment and maintenance) between AZ and External Suppliers and between GSQ and AZ Operations Sites
Complaints Management - Coordinate complaints issued for GSQ as a supplying site or coordinating site, Product Quality Complaints, Supply and Logistics (support when applicable), Product security
Supports GSQ Quality Management Systems
· Manages and maintains quality data and records in relevant quality management support systems (GQCLIMS, SAP and OCM) as required.
· SCA data entry and checks
· Stability Data entry and secondary data checks
· Assists in the production of, or contribution to, AZ quality documentation as GSQ SOPs.
· Manages internal deviations in Track wise deviation system.
· Supports with data for certification reports.
· Prioritisation of Certification reports to ensure optimal impact at sites
· Adherence to Certification report schedule
· Review of technical data
· Drafting, review and approval of Certification reports
· Upload of Certification Reports and Certification status to SCA
Facilitates process and system improvements, Support audits and inspection requests for sites and back up and support other team members
In addition to the above Key Accountabilities a Quality Supplier Manager at Career Level D is expected include in their remit the following:
Product Release - Assigns Usage Decision for Formulated and Packaged products (in accordance with Manufacturing License), Active Pharmaceutical Ingredients, Starting Materials, Medical Devices, including
Batch record reviews including working in relevant quality management systems and Assign Usage Decision for batches affected by Critical deviations, assessed by Senior Quality Supplier Manager or Qualified Persons
As assigned, serve as Business Process Owner(s) or Deputy BPO for the governance of the following systems:
Archiving, Audits - Self-Inspections - CAPA, Certification, Change Management System, Complaints Management System, Deviation Management System, Global Complaint Management System, IMT - Recall - FAR, Product Quality Review, Quality Assurance Agreements, SAOC - CoS, SCA database, SOPs and QCMs, Stability Management, Systems and IT
Education, Qualifications, Skills and Experience
Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
· Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
· Excellent oral and written communication skills in English
Specifically required essentials for Career Level D:
Demonstrated experience working cross-functionally and managing significant improvement initiatives (e.g. project management skills), Strong problem solving skills, Strong negotiating/influencing skills, Ability to work independently under his/her own initiative, Ability to travel nationally and internationally as required approximately 10% of their time.
Experience working in a PCO/PET organization or Lean/Six Sigma training, Multi-site / multi-functional experience, Proven experience in Quality Assurance or combination of Quality and Technical, Masters Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field