Quality Assurance Officer to AstraZeneca

Modis Life Science is looking for Quality Assurance Advisor for a consulting assignment at AstraZeneca in Södertälje. The assignment will initially run for 12 months and you will be hired as a consultant by Modis. Send your application ASAP, no later than March 25th.

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 Assurance Officer to join the Global Supplier Quality (GSQ) team.
Job description
The incumbent is responsible for 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.

QAOs 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
• Change control
• SOP management
• Stability Data entry and management
• Supply Chain Assurance (SCA) system administration
• Training System
• 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
• Temperature Excursion
• 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.

Product Release - Vaccine products (in accordance with Manufacturing License),
• Batch record reviews (including certificates of analysis/conformance, assessment of deviations as required) including working in relevant quality management systems (SAP, GQCLIMS).
• Assign Usage Decision for batches affected by Critical deviations, assessed by Senior Quality Supplier Manager or Qualified Persons
• Issuance of certificates within GQCLIMS system and manually.
Education, Qualifications, Skills and Experience

Essential

• Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering (Note: there may be specific additional requirements depending on the regulations in each country). 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.
• Previous experience of product release role
• Excellent oral and written communication skills [English and local language(s)]

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
• Strong problem solving skills
• Strong negotiating/influencing skills
• Ability to work independently under his/her own initiative
• Release experience within a Vaccines environment