Hiring for Validation Engineer

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profile Job Location:

Ahmedabad - India

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

Job Description:

Candidate must have experience from Pharmaceutical Industry and should be ready for traveling for site work across Gujarat and India also.

  • Execute CSV activities as per GAMP 5 21 CFR Part 11 and EU Annex 11
  • Prepare and execute validation deliverables:
  • Validation Plan / VMP sections
  • URS FS DS
  • Risk Assessments (FMEA / Risk-based)
  • 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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Required Experience:

IC

Job Description:Candidate must have experience from Pharmaceutical Industry and should be ready for traveling for site work across Gujarat and India also.Execute CSV activities as per GAMP 5 21 CFR Part 11 and EU Annex 11Prepare and execute validation deliverables:Validation Plan / VMP sectionsURS F...
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Key Skills

  • Python
  • SOC
  • Debugging
  • C/C++
  • FDA Regulations
  • Minitab
  • Technical Writing
  • GAMP
  • OS Kernels
  • Perl
  • cGMP
  • Manufacturing