AstraZeneca Pharmaceuticals LP Enablement Specialist in UAT team in Warsaw, Poland

Enablement Specialist in UAT team

Clinical Operations within Global Medicines Development (GMD) is accountable for the delivery of clinical studies.

Enablement drives the delivery of Business Process Excellence and Technology for the GMD Clinical Operations organisation, owning and providing industry leading process, technology and services on behalf of Clinical Operations and its internal and external Partnerships.

The Enablement Specialistin UAT (User Acceptance Testing) team is expected to be able to take the following roles within the team:

  • Quality Lead – overall accountability for User Acceptance Testing (process, timelines and quality), review and approve of the documents

  • Test Lead – responsible for creating User Acceptance Testing documentation (like Test Plan, Risk Assessment, Tractability Matrix, and Test Report), review of the User Requirement Specification (to understand testing requirements) and tracking testing issues

  • Tester – responsible for Test Scripts execution

  • The team members will be cooperating with:

  • Global Study Team representatives to clarify user requirements, scope of testing and intended system functionality;

  • Supply Chain Study Managers to receive input to the testing documentation Vendor Representatives (Project Managers) to set testing pre-requisites and work on testing issues

Essential qualifications:

  • University degree in related discipline, preferably in biological science or healthcare-related fields, such as medicine, nursing or sanitary engineering, or equivalent experience in the aforementioned disciplines

  • At least 2 year experience in Drug Development within a pharmaceutical or clinical background

  • Understanding of the clinical study and drug development process and ICH GCP guidelines in relation to study delivery operational activities

  • Ability to work collaboratively; proven organizational and analytical skills, and proven skills to deliver to time, cost and quality

  • Computer proficiency

  • Excellent knowledge of spoken and written English

  • Strong business communication and presentation skills

  • Ability to transfer knowledge efficiently (mentorship/trainings)

  • Some experience in Validation/User Acceptance Testing of computerised systems in a regulated environment, preferably the Pharmaceutical industry, including familiarity with documentation such as Validation/Test Plans, Reports, Test scripts (including test scripts execution), Functional Risk Assessment etc. and knowledge of regulatory (GxP, SOX etc.) requirements for computerised systems and infrastructure

Desirable qualifications:

  • Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement

  • Experience in the development and management of Business Process to deliver business performance

  • Comprehensive knowledge of ICH GCP

  • Some experience in IxRS/eCOA/ePRO/Spirometry/ECG solutions delivery

  • Some experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.