• Analyzing the technical specifications.

• Evaluation of the application to ensure meets project specifications.

• Developing testing strategies, testcases, etc organizing phased testing.

• Perform testcase executions.

• Monitoring errors in the system raising defects in Jira.

• Collaborating within the team across the the team.

• Creation of UAT data set-up and collaborating with medical affairs team on UAT.

• Follow good documentation practices per the process defined.

• Ensure deliverables are completed per schedule and are of good quality.

• Training the team and taking part in KT/Cross KT sessions.

• Performing review tasks within the team.

• Bachelors degree in Computer Science, Engineering, Life Sciences or related field required (Extensive experience and training may be considered in lieu of Bachelors degree.)

Experience

• 5+ years experience in validation/software testing required.

• Experience working with computer software including Word, Excel and SQL preferred

• 2+ years experience working with clinical trials and/or within pharmaceutical environment required

• Working knowledge of the drug development process including knowledge of FDA requirements for GxPs and 21 CFR Part 11 required

• Knowledge of software testing tools required.

• Proven ability in problem solving and troubleshooting.

• Proven mentoring and/or supervisory skills required.