CSV QA Lead

Job Details: • 8 to 10 yrs in medical devices, biotechnology with direct CSV exp • 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 independently. • Ability to interact and lead conversations and meeting with Business Partners independently to lead and guide GxP policies and regulations. Interact with technology partners to ensure compliant working and operation of supported GxP systems.