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 quick-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.

Interested candidate please drop mail to "[email protected]"

Regards,

Kushma

📌 Computer System Validation (Chennai)
🏢 HCLTech
📍 Chennai