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Validation Tester with regulatory compliance exp
Foster City, CA
Foster City
CA
94404
Date
: Jan-25-21
2021-01-25
2022-01-15
Validation Tester with regulatory compliance exp
Foster City, CA
Jan-25-21
Work Authorization
US Citizen
GC
H1B
EAD (OPT/CPT/GC/H4)
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Architect
Rate/Salary ($)
:
Market
Duration
:
LONG TERM
Sp. Area
:
Data Warehousing/ETL
Sp. Skills
:
x-Other
Consulting / Contract
CONTRACTOR
Direct Client Requirement
Required Skills
:
CAPA, GxP, QRT, regulatory compliance, Tester, Validation
Preferred Skills
:
Domain
:
IT/Software
Work Authorization
US Citizen
GC
EAD (OPT/CPT/GC/H4)
H1B
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Architect
Rate/Salary ($)
:
Market
Duration
:
LONG TERM
Sp. Area
:
Data Warehousing/ETL
Sp. Skills
:
x-Other
Consulting / Contract
CONTRACTOR
Direct Client Requirement
Required Skills
:
CAPA, GxP, QRT, regulatory compliance, Tester, Validation
Preferred Skills
:
Domain
:
IT/Software
Reqroute Inc.
Des Moines, IA
Post Resume to
View Contact Details &
Apply for Job
Job Description
:
Role : Validation Tester with regulatory compliance exp Location : Foster City , CA Primary skillset: Validation, Deviation / CAPA management, Document control, change management Align activities as per expectation set for QRT Ensures the deliverables and tasks are adhered to the Client Process & CPI/KPI's Organize and moderate the deviation investigation meeting Moderate the root cause analysis meeting Prepare the interim documents on the required fields of Track wise or Deviation, CAPA, Change management, Emergency Change management Update the fields of the Track wise workflows from the approved content of interim documents Collaborate and follow up to complete the activities on time by the action owners of Deviation, CAPA, Change management, Emergency Change management Support/Perform Team lead on Periodic GxP reviews as per plan Plan, perform and report the Periodic GxP reviews Support the Sr. lead on exploring the opportunities for improvements in Client Process/Guidelines/Templates Support on improving the Client SOP's/templates Follow up with the stakeholders on the open action items on the action items arrived from the Deviations/CAPA/Periodic GxP Reviews/Document Control/Effectiveness Check Escalate well in advance in case of progress by action owner is not as expected Assist lead in preparing the Do's/Don'ts Share the data for metrics to the QRT lead Completing the trainings on time Thanks &
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