Validation Lead

Senior Consultant - Computer System Validation

Mandatory skills - Computer System Validation, GxP Regulations, Validating GxP systems

• 8-10 years' experience in Computer System Validation ERP/WMS, R&D systems

• 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 of Cloud Based qualification and validation, CI/CD methodology, Jenkins and Bitbucket usage preferred.

• Experience with Backup & Restore GxP activities preferred.

• Proficient knowledge on 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 Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams