Hiring for Validation Engineer

Ahmedabad - India

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description:

Execute CSV activities as per GAMP 5 21 CFR Part 11 and EU Annex 11
Prepare and execute validation deliverables:
o Validation Plan / VMP sections
o URS FS DS
o Risk Assessments (FMEA / Risk-based)
o IQ OQ PQ protocols and reports
Validate systems such as PLC Lab Computerized Systems LIMS QMS DMS ERP SAP SaaS and custom applications
Execute test scripts collect evidence and maintain traceability
Work on multiple client projects simultaneously and meet delivery timelines
Support internal client and regulatory audits (USFDA EMA MHRA WHO PIC/s
Participate in client meetings and audit discussions including global time zones if required

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Job Description:Execute CSV activities as per GAMP 5 21 CFR Part 11 and EU Annex 11Prepare and execute validation deliverables:o Validation Plan / VMP sectionso URS FS DSo Risk Assessments (FMEA / Risk-based)o IQ OQ PQ protocols and reportsValidate systems such as PLC Lab Computerized Systems LIMS Q...