Solution Architect – Validation & Testing
West Pharmaceutical Services
full-time
Posted on:
Location Type: Office
Location: Bengaluru • India
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About the role
- Handle various computer system validation activities for different cross functional programs across West Pharma.
- Lead and execute validation activities for GxP computerized systems in compliance with global regulatory requirements (FDA, EU Annex 11, GAMP 5, CSA).
- Author, review, and execute validation deliverables (VP, URS, RA, IQ/OQ/PQ, RTM, VSR).
- Guide cross-functional teams (QA, IT, Engineering, Manufacturing, Vendors) to ensure validation requirements are properly integrated during system implementation and changes.
- Participate in internal audits and regulatory inspections, providing validation rationale and documentation support.
Requirements
- Requires bachelor’s degree in computer science or Information Technology
- Minimum 3 years of relevant experience (preferably in Medical Device or Pharma validation of Software)
- Prior working knowledge on tools like SAP, QMS, LIMS
- Good understanding of GxP computerized system lifecycle principles (GAMP 5)
- Ability to guide cross-functional teams in integrating validation requirements during system implementation
- Prior knowledge on documentation review skills with attention to compliance, traceability, and audit readiness.
Benefits
- health insurance
- paid time off
- professional development programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
computer system validationGxP computerized systemsvalidation deliverablesVPURSRAIQ/OQ/PQRTMVSRdocumentation review
Soft Skills
leadershipguiding cross-functional teamsattention to compliancetraceabilityaudit readiness