Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 12 month(s)
No Travel Required
Skills
jira
SDLC
GxP Regulations
Job Details
Mandatory Skills - Computer System Validation, GxP Regulations, Validating GxP systems
Job Details:
- 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
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