CSV QA Lead

Role - CSV QA Lead

Location - Raritan, NJ(Hybrid)

Buy Rate - $52/hr on W2

Computer System Validation - Infrastructure qualification and Tool validation in Medical Devices space

Business Separation and Demerger related CSV knowledge

Infrastructure Qualifications, Large Migration project exposure

Job Details:

• Medical devices, biotechnology with direct CSV experience
• Practical knowledge of GxP regulations and standards - 21 CFR part 11, Part 210/211, GAMP 5, EU Annex 11, security and privacy requirements
• Exp in leading GxP infrastructure qualification and quality oversight of on prem or cloud environments with working knowledge of networks, databases, virtualization, ITIL process, disaster recovery and infrastructure security controls
• Exp with Jira/Xray, qtest or equivalent ALM/test platforms
• Looking for an offshore resource to support a fast-paced ongoing validation project. Some of the high-level requirements for this role are -
• A senior consultant with expert knowledge of GxP and Computer System Validation.
• Expertise in authoring and reviewing all CSV validation deliverables. Proficient in Compliance Plan, User Stories, Testing, Traceability Matrix and SDLC lifecycle activities.
• Knowledge in utilizing SDLC tools such as JIRA, AM, qTest, X-ray etc.
• Proficient knowledge of CFR Part 11 regulations and Quality Management Regulations.
• Prefer an individual with great communication skills, ability to work proactively and Consultantly.
• Ability to interact and lead conversations and meeting with Business

Partners Consultantly to lead and guide GxP policies and regulations. Interact with technology partners to ensure compliant working and operation of supported GxP systems.

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