As the independent second line assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients. The QSS Specialist plans and manages technical and logistical services in compliance with document and system standards within the document management systems (AZ-Doc) and/or other systems within the remit of the QSS team such as Learning Management Systems.  Acts as a point of contact and support for authors of Procedural Documents, Process Owners and Process Area and Learning Leads.

Job Specific General Accountabilities:

• Documentation Support:

- Conducts tasks related to publishing of procedural documents (PDs), including maintenance activities for the Document Management System housing the PDs. 

- Liaises effectively with the representatives of assigned business areas, authors, reviewers or approvers of PDs to achieve understanding and good working practices relative to PD changes and publishing.

- Provides system support for the users working with Standard Documents (e.g. system validation documents)

- Manages user access to the document management system.

• Administration Activities (documentation):

- Contributes to the implementation and maintenance of systems, platforms and processes in the remit of the Quality Standards and Systems team (e.g. clean-up activities in the systems, UAT, property updates).

- Supports audits/inspections in retrieving data from the DMS (Document Management System) and LMS (Learning Management System).

- Provides metrics to customers and runs reports in the DMS.

- On request provides support on the use of the systems/platforms within the QSS remit.

- Contributes to the development and maintenance of reference materials.

- Analyses the queries from the user community to identify improvement opportunities in reference materials and processes.

• Quality Assurance General Accountabilities:

- Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines

- Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits

- Communicates effectively with QA colleagues and business stakeholders

- Maintains knowledge of relevant industry information affecting quality and compliance arena

- Leads training for colleagues and business stakeholders as required.

- Involved in and may lead the development and/or revision of QA processes, projects and tools

- Mentors QA colleagues

Provides general support related to regulatory authority inspections as and when required

Education, Qualifications, Skills and Experience:

• Degree level education
• Experience in pharmaceuticals or a related industry
• Excellent analytical, written and oral communications skills
• Proven expertise in system administration and information management
• Experience in pharmaceuticals or a related industry and a good understanding for business processes within area of accountability
• Fluent in written and spoken English
• High ethical standards, trustworthy, operating with absolute discretion
• Strong collaborative, influencing and interpersonal skills – curious to understand business environment
• Skilled at managing & using technology Ability to maintain and create professional networks with stakeholders
• Project management
• Document Management

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.