Enablement Specialist in UAT team
Warszawa Enablement Specialist in UAT team
Warszawa
NR REF.: 1105524
About us
AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.
The role
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 Specialist in UAT(User Acceptance Testing) team is expected to be able to take the following roles within the team:
Essential qualifications:
Desirable qualifications:
We offerstable employment conditions, wide benefit package and the opportunity to participate in building a new team .If you would like to apply for the above position, please send your application documents (actual curriculum vitae) in English.
Warszawa
NR REF.: 1105524
About us
AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.
The role
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 Specialist in 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)
- Exhibit of AZ Values and Behaviours
- 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:
- Expert reputation within AZ business area
- 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
We offerstable employment conditions, wide benefit package and the opportunity to participate in building a new team .If you would like to apply for the above position, please send your application documents (actual curriculum vitae) in English.
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