Vacancy expired!
- Understand the functional User Stories in detail and update the User Requirements Specification/ Functional Requirements Specification (URS/FRS) Document at each Sprint Level.
- Work closely with Business Systems Owner to define requirement criticality (Critical/Non Critical/Other) and update the URS/FRS accordingly.
- Work very closely with the Validation Team during the validation testing phase of the project and involve other project resources as needed.
- Participate in the requirements sessions scheduled with the vendor to understand business requirements in detail.
- Update Configuration Document as needed based on the requirements.
- Analyze opened issues by Project team QA resource, Validation team and end users and identify if the issue is a defect or a new requirement.
- Update the Change record to populate the required content, identify the required deliverables by discussing with team, get the change record peer reviewed and approved.
- Document User Acceptance Letter, Identification of Supporting System Document and Risk Assessment Document.
- Perform system testing as needed
- Participate in and sometimes lead Agile Ceremonies such as daily stand up meetings, Sprint Planning sessions and Sprint Demonstrations to understand the implementation of the functionality.
- Minimum 5 to 7 years BSA experience required.
- BS degree Computer Sciences or related field
- Experienced in writing requirements for projects in pharmaceutical company is a MUST.
- Experience in developing risk assessments, validation plans, protocols, test scripts and reports that support the qualification and validation of GxP systems.
- Collaborative, positive, self-motivated, team player.
- Experienced in working with multiple groups and cross functional departments.
- Experienced in managing technology deliverables or documents from requirements through implementation.
- Strong communication skills; verbal and written
- Experienced with MS Outlook, Visio, PowerPoint, Word, Excel.
- Work on SLDC documents such as User Requirements (URS), and Functional Requirements (FRS) documents and User Acceptance (UAT) Letter
- Previous working experience in Agile methodology
- General working knowledge of Clinical study activities
- Experience with Clinical systems highly valuable
- Working experience JIRA
- Note: This position will be onsite at ABV1 location in Mettawa after COVID-19 restrictions are lifted and space is made available.
- Experience creating SDLC documents
- Great communication skills – ability to communicate with both business and developers
- Experience in both Agile and Waterfall environment for SDLC
- General working knowledge of Clinical study activities
- Experience with Clinical systems highly valuable
- Working experience JIRA
Vacancy expired!