Validation consultant
Validation consultant
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Salary Not Disclosed
1 Vacancy
Job Description
Roles and Responsibilities:
- Mandatory Skills Computer System Validation GxP Regulations Validating GxP systems
- 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 Xray 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 guidances 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.
- Skill (Primary) Domain Competencies (APPS)Pharma Validation & VerificationComputer System Validation (CSV).
Employment Type
Full Time
