Job Description :
Hello ,

Hope you are doing Great!
This is Lokesh from Keylent Inc.

We have an Urgent opening for “Sr. Business Systems Analyst” position in Foster City, CA

Role: Sr. Business Systems Analyst
Location: Foster City, CA
Duration: 12+ months

Note: Need local

IT GXP (Validation Process) EXPERIENCE
Local on-site Senior Business Analyst with IT GxP process and Business Process implementation experience. The individual we are looking is a seasoned Senior Business Analyst with strong core skills, including communication, leadership, taking the initiative, and driving for results with little support from other BA team members. This person will need to be able to work in a very fast-paced and dynamic environment, yet, bring organization and control to the track(s) of BA work they manage.

Mastered Skill:
Implement advanced strategies for gathering, reviewing and analyzing requirements
Prioritize requirements and create conceptual prototypes and mock-ups
Master strategic business process modeling, trace ability and quality management techniques
Apply best practices for effective communication and problem-solving
Creates clear and concise documentation

Requirements:
7+ years analyst experience preferred.
Ability to elicit business requirements and translate into technical documents
Understanding of GAMP 5, 21 CFR part 11, and Computer System Validation
Experience authoring and updating SOP''s. Experience in navigating deviations, CAPA''s and CC''s.
Experience with complete software development life cycle.
Experience designing and reviewing test cases. Experience with QA (GxP) process methodology
Knowledge of SharePoint or similar collaboration portal
Self-starter with strong problem solving skills
Excellent verbal and written communication skills.

Responsibilities:
Partner with cross-functional stakeholders (i.e.: Technical team, Validation/Qualification team and Business counterparts, etc to elicit, analyze, and translate information to create Business Requirement , User Requirements, and/or Technical Requirements
Act as a liaison between technical teams, and the business community, including managing communications between business stakeholders and technical teams
Lead effort to obtain approvals for all types of Requirements
Manage user change requests and change process
Design comprehensive test plans to test the quality of software and business processes
Work with IT Technical team, Business counterparts, etc. to gather information to create User Acceptance Test Strategy documents
Coordinate and manage user acceptance testing by providing test schedules, planning, test data, detailed test scripts and document test results
Lead effort to obtain approvals for UAT Testing Summary, including the creation of the summary itself.
Thanks&
             

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