Responsibilities :
- 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.
- Assists 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.
Requirements :
- 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.
- Ability 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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