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Process Validation Engineer---Contract//New York City NY/Hybrid // Local Only at New York City, New York, USA
Email: [email protected]
Process Validation Engineer

Location: New York City NY/Hybrid

Duration: Contract

The team should have experience (7+) in Computer System Validation, 21CFR Part 11 and GCP.

a. Quarterly check point reports that outlines the below:

i. Operational status/metrics

ii. Areas of improvement/observations

iii. Short term course corrections/remediation

b. Validation Reports containing review comments of validation packages for releases

c. Validation Certificates

d. Validation metrics on open vs. closed validation observations with impact, criticality, and status

e. Validation Standard Operating Procedures (SOP), Work Instructions (WI), Guidance Documents, Templates Regulatory Adjustment/Remediation if required

f. Weekly and Monthly status updates on validation progress on each of the releases assigned

g. Determination of scope for subsequent quarter (agreed in conjunction with Medidata P&V leadership) for business continuity and improvement

Thanks & Regards

Rohit Patil

Recruitment Lead

[email protected]

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Keywords: information technology New York Wisconsin
Process Validation Engineer---Contract//New York City NY/Hybrid // Local Only
[email protected]
[email protected]
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Tue Oct 22 20:33:00 UTC 2024

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