Quality Assurance Assistant

 Typical Accountabilities
• Execute core processes applicable to own area of internal / external quality (e.g. deviation management system; global complaint management system, supplier management, product quality reviews).
• Conduct timely data entry and documentation related to own quality area.
• Advise on deviations to make batch disposition recommendations to approve or reject batches.
• Review and approve investigations to ensure root cause is established and relevant CAPAs are in place.
• Conduct customer complaint investigations and approve investigation reports.
• Conduct ongoing reviews and approvals of documentation as applicable (i.e. changes within the change management framework; validations and qualifications; product quality reviews, periodic reports, regulatory documents, and change errands).
• Provide advice on GxP within the site, with reference to guidelines and regulations.
• Lead formal and informal training including GMP training.
• Coordinate referrals of regulatory documentation (e.g. dossiers, site impact assessment, annual reports, or QP declarations) and market-specific documentation for site accreditations and product reviews.
• Support process improvements and risk assessments, such as benchmarking internal and external quality assurance practices to identify innovative efficient and effective practices.
• Support data analysis and development of reports and insights on quality metrics and key performance indicators, using digital tools and processes.

Typical People Management Responsibility (direct / indirect reports)
0
What is the global remit?
•
(how many countries will the role operate in?)

Education, Qualifications, Skills and Experience

Essential:
• High school education with experience or Entry level bachelor’s degree in science / engineering field such as Pharmacy, Biology, or Chemistry.
• Experience working with principles and concepts of compliance management related to GxP, SOPs, & SHE requirements.
• Relevant experience in executing quality management processes within a highly regulated environment.
• Experience working with digital tools and applications related to QA reporting, documentation, and analysis.

Desirable:



Key Relationships to reach solutions

Internal (to AZ or team)
• Process Execution Team
• External Quality
• Regulatory
• Global Quality
• On Market technical
• Operational Excellence

External (to AZ)
• Health Authority Inspectors
• Vendors 

Date Posted

Closing Date

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.