*Please go through the below requirement and Share Suitable profiles
to **srini...@softhq.com
<srini...@softhq.com>.*
*Job Title: IT Validation Lead*
*Location: Westlake Village, CA*
*Duration: 6+ months*
* Job Description:*
· Creating validation deliverables in line with the Baxter
Corporate Quality Procedure guidance.
· Ensuring the validation approach for IT systems is done in a
harmonized and standardized fashion. Develop templates and stream line
processes.
· Optimizing the validation approach for IT systems used in
Serialization and e-pedigree project. Oversee and co-ordinate the
validation deliverables/execution at local manufacturing sites.
· Assuring, in association with the project QSR, that a
system/application meets its requirements and is compliant with applicable
Baxter QMS documents, and the documentation set outlined in the Validation
Plan for the project.
· Supporting a CSO and QSR in all GxP regulations, compliance with
internal and external procedures, and all aspects of safe, reliable, and
consistent operation of the computerized system.
· Reviewing validation life cycle documentation from validation
function/SME perspective for Supply Chain Security portfolio projects.
· Perform Risk Assessment, Quality Assessment and 21 CFR assessment
for IT systems.
· Ensuring adequate procedures are in place for computerized
systems implementation, use, and support.
*Thanks & Regards*
*Srinivas Badiganti* | *Technical Recruiter*
*SoftHQ, INC*
*Consulting – Development – Staffing*
*Email:* srini...@softhq.com
*Phone: 858-658-9200 x 620*
*Gtalk / YIM: bsrao.recruiters*
*Certified Women Owned Minority Business Enterprise {WMBE}
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