Katalyst Healthcares and Life Sciences
Responsibilities:
- Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy / Test Planning, Validation / Test Summary, Requirement Trace Matrix.
- Possesses strong communication skills to interact with business stakeholders (Technology Leader, Project Manager, Business Owner).
- Ability to work with project team to facilitate interaction between Project team and Business Stake holders.
- Ability to manage and provide guidance / train the team on Policies, end to end SDLC Process, Procedure and Tools.
- Trains the project team on the relevant procedures associated with different SDLC processes and Tools.
- 3-7 years' experience in Computer System Validation or Quality Management or Business Analysis in GxP application area.
- Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA.
- Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC.
- Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams.
- The resource must have experience in Tool validation - ServiceNOW, JIRA, Automation tools.
- Strong in Project Management tools like JIRA.
- Manage Project priorities based upon identified risks.