Senior Technical Lead

Chennai, Tamil Nadu

Job Summary

- Resources are expected to help with compliance projects for updates to Quality Workbench (GAMEs).
- Looking for an offshore resource to support a rapid-paced ongoing validation project to complete by the end of this year.
- 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.
- Knowledge with validation of analytics platforms preferred.
- Proficient knowledge of CFR Part 11 regulations and Quality Management Regulations.
- Expertise in SOP and WI authoring and reviews.
- Proficient with change control management and utilization.
- 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.

Key Responsibilities





- Resources are expected to help with compliance projects for updates to Quality Workbench (GAMEs).
- Looking for an offshore resource to support a fast-paced ongoing validation project to complete by the end of this year.
- 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.
- Knowledge with validation of analytics platforms preferred.
- Proficient knowledge of CFR Part 11 regulations and Quality Management Regulations.
- Expertise in SOP and WI authoring and reviews.
- Proficient with change control management and utilization.
- 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.

Skill Requirements

Other Requirements

📌 Senior Technical Lead (India)
🏢 HCLTech
📍 India