ROLE VALIDATION and TESTING ANALYST
INTERVIEW pre-qualifying Video Assessment, MS TEAMS conversation
Validation and Testing Analysts (5)
- 3-5 years experience in Life Sciences.
3-5 years experience in Validation and Testing.
As a Validation and Testing Analyst, you will be responsible for ensuring the accuracy, reliability, and compliance of software applications within the life sciences industry.
- Your primary focus will be on validation testing of eCOA systems and other related technologies.
Must Be able to:
- Validation Testing: Perform comprehensive validation testing of software applications used in the life sciences sector, including systems such as Clario Oracle Inform, and Metadata Rave.
- Test Script Development: Create and execute test scripts for decentralized trials, with a particular emphasis on testing involving handheld devices.
- Validation Planning: Contribute to validation planning activities, including the development of test strategies, test plans, and risk assessments.
Overall Key Responsibilities:
- Stakeholder Collaboration: Engage with stakeholders to gather and understand validation requirements, ensuring compliance with relevant regulatory standards.
- Documentation: Maintain detailed documentation of test results, including defects and deviations. Participate in defect triage and resolution processes.
- Regression Testing: Conduct regression testing to validate software changes and updates – if and when required for systems upgrades
- Cross-Functional Collaboration: Work closely with developers, business analysts, and quality assurance teams to achieve successful validation outcomes.
- Continuous Improvement: Support and drive initiatives aimed at improving validation processes and testing methodologies.
- Training and Support: Offer training and support to team members as required to facilitate effective validation practices.
Qualifications:
- Must have Experience: Prior experience in validation testing, within the life sciences or pharmaceutical industries.
- Must have Specialized Knowledge: Proficiency with eCOA systems, handheld devices, and decentralized trial environments. Knowledge and understanding of GCP and GxP standards is essential.
- Must have Validation Expertise: In-depth knowledge of validation principles, methodologies, and regulatory requirements (e.g., FDA regulations, GAMP guidelines).
- Must have Technical Skills: Experience with software testing tools and methodologies.
- Problem-Solving: Strong analytical skills with the ability to resolve complex issues effectively.
- Communication: Excellent interpersonal and communication skills, with the ability to collaborate effectively across teams.
- Attention to Detail: Meticulous attention to detail with the capability to work independently and as part of a team.
- Certifications: Relevant certifications in software testing or validation (e.g., ISTQB) are advantageous.