Validation and Testing Analyst

Role: VALIDATION and TESTING ANALYST

Experience: 8+yrs

Working Hours: Overlap

Office Location: Remote 100%

Interview: Virtual

Job Description:

Validation and Testing Analysts
8 years experience in Life Sciences
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.

Please share your Resume at asingh21@fcsltd.com