Job Description

• New Billing, Exclusive, Potential Computer System Validation Validating SAP system and other manufacturing systems.
• Minimum 10 years regulated industry experience preferred with Computer System.
• Validation or Quality management or Business Analysis in GxP application area.
• pplication 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.
• Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner & Business users / SME) and interpret business rules and documents them for software development.
• Resource has to be Knowledgeable and extensive experience performing computer systems validation (CSV) remediation type activities (i.e., GxP identification, Gap Analysis, Executing Test Scripts, Documenting Rationale, Preparing Plans/Report, Presenting Status Updates to stakeholders, etc.).
• Working knowledge of ISO and CFR (211, 820, Part 11) requirements, Possesses strong communication skills to interact with business stake holders Should be able to handle and guide multiple GxP projects.
• bility to work with project team to facilitate interaction between Project team and Business Stake holders.
• bility 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.
• Must be able to work independently and Lead Project Teams, Excellent verbal and written skills required.
• Previous CSV, regulatory remediation or due diligence experience is a must.
• Travelling to West coast (up to 50%).
• To architect, design and develop (through Team) solution for product or project and sustenance delivery.
• To support as an Subject Matter Expert.
• To ensure knowledge up-gradation and work with new technologies so that the solution is current and meets quality standards and the client requirements.
• Ensuring a sufficient pool of skilled professionals in the designated technology, through activities such as conducting interviews, providing training sessions and offering mentorship.
• To gather specifications and deliver solutions to the client organization based on understanding of a domain or technology.
• To support competency development with envisioning and articulating propositions building collateralsor whitepaper creation, market trend analysis etc.
• To recommend client value creation initiatives and implement industry best practices (on specific technology or product).

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