Title: Computer System Validation with Life Sciences
Location: Bangalore
Exp: 6 years
Job Description:
Role Descriptions: Validation Engineer57 years of experience in Computer System Validation (CSV) and Computer Software Assurance (CSA).Solid knowledge of GxP regulations (FDA 21 CFR Part 11 EU Annex 11 GAMP 5).Experience in risk-based validation approach aligned with CSA in creating validation plans RTM IQOQPQ and summary -on experience validating GxP systems (LIMS QMS ERP MES CloudSaaS).Proficient in change control deviation and CAPA working with AgileSDLC validation to support audits inspections and compliance documentation review and stakeholder coordination understanding of data integrity (ALCOA) and system lifecycle management.
Essential Skills: Validation Engineer5 -7 years of experience in Computer System Validation (CSV)
and Computer Software Assurance (CSA).Robust knowledge of GxP regulations (FDA 21 CFR Part 11 EU Annex 11 GAMP 5).Experience in risk-based validation approach aligned with CSA in creating validation plans RTM IQOQPQ and summary -on experience validating GxP systems (LIMS QMS ERP MES CloudSaaS).Proficient in change control deviation and CAPA working with AgileSDLC validation to support audits inspections and compliance documentation review and stakeholder coordination understanding of data integrity (ALCOA) and system lifecycle management.
Desirable Skills:
Keyword:
Skills: Life Sciences : Computer System Validation
📌 Computer System Validation With Life Sciences Bengaluru
🏢 NR Consulting
📍 Bengaluru
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