Quality Supplier Managers to AstraZeneca in Södertälje
Poolia Sverige AB / Apotekarjobb / Stockholm
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hela Sverige Visa alla jobb hos Poolia Sverige AB i Stockholm,
Solna,
Lidingö,
Sundbyberg,
Danderyd eller i
hela Sverige We are recruiting a Quality Supplier Manager to AstraZeneca's Global Supplier Quality (GSQ) team for an temporary assignment that will start as soon as possible. Do you have a university degree in Pharmacy, strong problem solving and negotiating skills and the ability to work independently under your own initiative? Please don't hesitate and submit you application already today. We are looking forward to your application.
Job description
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
Key Accountabilities
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.
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
Other
• Facilitates process and system improvements
• Support audits and inspection requests for sites
• 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
• 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
Essential
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.
Desirable
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
ABOUT ASTRA ZENECA
About AstraZeneca
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.
OM POOLIA - VAD VI KAN ERBJUDA DIG
Vi på Poolia Life Science är specialister som rekryterar specialister inom life science. Självklart omfattas din anställning på Poolia av kollektivavtal, försäkringar och tjänstepension. Vi vill att Du ska må bra och trivas med oss på Poolia och därför erbjuder vi Dig friskvårdsbidrag, företagshälsovård och ordnar regelbundet sociala aktiviteter. Hos oss får du en engagerad konsultchef som finns tillgänglig och håller löpande kontakt med Dig och kundföretagen under hela din anställning. Vårt mål är att vi ska trivas och utvecklas tillsammans
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2020-01-13ErsättningFast lön
Så ansöker duSista dag att ansöka är 2020-01-20
Klicka på denna länk för att göra din ansökanFöretagPoolia Sverige AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "55856".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Poolia Sverige AB (org.nr 556426-7655),
http://www.poolia.se Arbetsplats Poolia Life Science & Engineering AB
Jobbnummer 5038845
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