Job Description

• Develop Test/Validation Master Plan and test strategies.
• Develop detailed Test/Validation scripts.
• Lead testers through aggressive test cycles. This includes leading the Business Testers and interacting with Development where required to complete the necessary work.
• Tracking and report on testing status and outcomes.
• Identifies and logs defects and issues found during testing and the follow up around those issues.
• Prepare and maintain requirement traceability matrix.
• Proactively looks for continuous improvement opportunities with the test methodology and best practices to support quality.
• Ensure the necessary testing artifacts are complete and accounted for to support auditability.
• ssists with the planning of quality assurance task assignments, scheduling, and estimates.
• Provide updates and status reports to the Project Manager around progress and any issues or blockers.

• Strong understanding of FDA guidance on electronic records and validation procedures.
• Experience working with a Pharmaceutical, Biotech or Medical Device organization.
• Experience working with Jira.
• Experience working in an agile delivery environment.
• bility to handle multiple priorities and work under pressure. Professional communication skills a must.
• Good functional knowledge of Life Sciences commercialization processes.
• Previous experience with the following tools is Required.
• Veeva Sales CRM, Medical CRM, and Salesforce CRM.
• Familiarity with the following is a plus.
• Experience with Commercial Data (KOL, HCP, HCO, Prescription, Sales Territories etc.

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