Greetings from HCL Tech Hiring for Computer System Validation Location
- Bangalore / Noida / Pune / Hyderabad / Chennai JD : Mandatory Skills 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
• 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
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• 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 excellent 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. Interested candidate please drop mail to "[email protected]" Regards, Kushma

📌 Computer System Validation (Chennai)
🏢 HCLTech
📍 Chennai