Job Description
Roles & Responsibilities :
- 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
- Authoring of URS/FS, protocols, final reports, validation plan/report
- High-level understanding of Veeva Vault suits
- Risk-based testing aligned to CSA fundamentals
- High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP
Education & Experience :
- Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy
- Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system
Skills
Artificial Intelligence (AI)unmatched
Biostatisticsunmatched
Code of Federal Regulationsunmatched
Computer Skillsunmatched
Computer Systemsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
GxPunmatched
ISO 9001unmatched
ITIL (IT Infrastructure Library)unmatched
Medical Affairsunmatched
Pharmacovigilanceunmatched
Pharmacyunmatched
Regulationsunmatched
Research & Development (R&D)unmatched
Riskunmatched
Sarbanes-Oxley Act (SOX)unmatched
Standard Operating Procedures (SOP)unmatched
System Validationunmatched
Systems Engineeringunmatched
Testingunmatched
Validation Planunmatched
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