My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and are looking to recruit a Senior Regulatory Consultant on...
Enablement Specialist - part of User Acceptance Testing (UAT) team - Warsaw, Poland Full-time, Permanent, Office-Based.Very strong and competitive package.Candidates from outside of Poland are encouraged to apply as well.
Prestigious position in the Global Medicine Development within an advanced and highly renowned Pharmaceutical Company based in the Warsaw area in Poland. The ideal candidate to join the User Acceptance Testing (UAT) team will have a thorough knowledge of clinical systems delivery and/or system validation/testing. He/she will be working collaboratively with internal and external customers and stakeholders to ensure the study specific systems and integrations between them meet the user requirements and intended use.
Main Accountabilities will include:
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.
- Experience in systems development and/or validation/testing (essential)
- Ability to work collaboratively with external partners in delivering mutual benefit (essential)
- University degree in related discipline, preferably in biological science or healthcare-related fields, such as medicine, nursing or sanitary engineering or equivalent experience;
- A minimum of 2 years of 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;
- Fluency in English;
- Experience in IxRS delivery, UAT documentation creation and Test Scripts execution (desirable)
- Solid understanding of technology associated with the clinical development process, preferably with extensive experience of computerised systems in the Pharmaceutical industry, including familiarity with documentation such as Validation/Test Plans, Reports, Test scripts etc. and knowledge of regulatory (GxP) requirements for computerised systems and infrastructure (desirable).
WANT TO APPLY?
For an immediate consideration please press 'apply' or alternatively contact Emanuele either via email () or on the phone (+44 0203 910 9516) now and get more information about the role.
Our team at SRG Clinical also cover roles in Biometrics, Medical Affairs, Clinical Operations, Medical Information, Pharmacovigilance and Regulatory affairs so do not hesitate to get in touch.
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The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.