What are the responsibilities and job description for the Validation QA for NY/ NJ position at Tekshapers Inc?
The team should have experience (10 ) in Computer System Validation, 21CFR Part 11 and GCP.
- Quarterly check point reports that outlines the below:
- Operational status/metrics
- Areas of improvement/observations
- Short term course corrections/remediation
- Validation Reports containing review comments of validation packages for releases
- Validation Certificates
- Validation metrics on open vs. closed validation observations with impact, criticality, and status
- Validation Standard Operating Procedures (SOP), Work Instructions (WI), Guidance Documents, Templates Regulatory Adjustment/Remediation if required
- Weekly and Monthly status updates on validation progress on each of the releases assigned
- Determination of scope for subsequent quarter (agreed in conjunction with Medidata P&V leadership) for business continuity and improvement
Tekshapers is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
