Computer System Validation Lead

Supporting and Validating Regulatory systems like REMS RIMS

10+ years experience in Computer System Validation of Regulatory systems like Regulatory Information Management System, REMS, Publishing, eCTD systems used in Pharmaceutical industry.

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 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.

Possesses strong communication skills to interact with business stakeholders (Technology Leader, Project Manager, Business Owner, Business users, SME) and interpret business rules and requirements and documents them for software development.

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.

Should be able to handle and guide multiple GxP projects.

Ability to work with project team to facilitate interaction between Project team and Business Stakeholders.

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. Strong in Project Management tools like JIRA.

Manage Project priorities based upon identified risks.

Soft Skills:
(1.) To troubleshoot and resolve critical and complex tickets.
(2.) To create the root cause analysis for critical issues or faults (hands-on working).
(3.) To implement any necessary preventive measures to reduce future defects.
(4.) To provide technical assistance to the team members in resolving customer issues.
(5.) To execute continuous improvement activities and to improve the team's performance. #J-18808-Ljbffr