NC
Computer System Validation with Life Sciences
NR Consulting - India
🇮🇳 India
On-site
4 months ago
- GxP
- ERP
- CAPA
4 months ago
Location: Bangalore
Exp: 6+ years
Job Description:
Role Descriptions: Validation Engineer57 years of experience in Computer System Validation (CSV) and Computer Software Assurance (CSA).Strong knowledge of GxP regulations (FDA 21 CFR Part 11| EU Annex 11| GAMP 5).Experience in risk-based validation approach aligned with CSA principles.Expertise in creating validation plans| RTM| IQOQPQ| and summary reports.Hands-on experience validating GxP systems (LIMS| QMS| ERP| MES| CloudSaaS).Proficient in change control| deviation| and CAPA management.Experience working with AgileSDLC validation models.Ability to support audits| inspections| and compliance assessments.Strong documentation| review| and stakeholder coordination skills.Good 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).Strong knowledge of GxP regulations (FDA 21 CFR Part 11| EU Annex 11| GAMP 5).Experience in risk-based validation approach aligned with CSA principles.Expertise in creating validation plans| RTM| IQOQPQ| and summary reports.Hands-on experience validating GxP systems (LIMS| QMS| ERP| MES| CloudSaaS).Proficient in change control| deviation| and CAPA management.Experience working with AgileSDLC validation models.Ability to support audits| inspections| and compliance assessments.Strong documentation| review| and stakeholder coordination skills.Good understanding of data integrity (ALCOA) and system lifecycle management.
Desirable Skills:
Keyword:
Skills: Life Sciences : Computer System Validation
Computer System Validation with Life Sciences · NR Consulting - India