Oracle Principal Consultant – Validation

Oracle Principal Consultant – Validation & Compliance 4 days ago Be among the first 25 applicants Direct message the job poster from Trinamix Inc Trinamix is recruiting a Canada-based Senior/Principal Validation & Compliance Consultant to lead the GxP, 21 CFR Part 11, Annex 11, and CSA validation workstream for the Canadian and U.S. based Life Science Oracle Cloud ERP implementation. This senior role requires deep understanding of: Canadian manufacturing and nutraceutical GMP environment GxP-critical processes in Supply Chain, Inventory, Quality, and Manufacturing Oracle Cloud ERP validation and SaaS compliance OIC, integrations, audit trails, data integrity controls The consultant will work closely with Trinamix onshore architects, our offshore implementation teams, and Vita Health’s Quality & Regulatory Assurance teams. Key Responsibilities 1. Lead the Validation Program for Oracle Cloud ERP Implementation Serve as the Validation Lead for the entire ERP program. Create and manage all core validation deliverables: Intended Use & GxP Impact Assessment GAMP 5 Application Categorization 21 CFR Part 11 / Annex 11 Assessment Requirements Traceability Matrix (RTM) PQ/OQ scripts for GxP processes Validation Summary Report (VSR) Ensure alignment with Health Canada, FDA, ICH Q9/Q10, ISPE/GAMP 5, and customer SOPs. 2. Validate Oracle Cloud ERP for GxP & Canadian Regulatory Requirements Validate configurations and process controls across: Inventory, Warehousing, Lot Control Manufacturing & Batch Records Quality Management Costing & Financial Controls where applicable Identify GxP-critical process steps requiring additional control, evidence, or testing. Ensure data integrity (ALCOA+), audit readiness, and proper segregation of duties. 3. 21 CFR Part 11, Annex 11 & Data Integrity Qualification Assess and validate: Electronic Records & Electronic Signatures Audit Trail completeness for Oracle Cloud Controlled system access and privilege restrictions Provide actionable remediation recommendations for compliance gaps. 4. Validate OIC Integrations, Extensions & Reports Auditability Data transformation integrity Logging and traceability Change management controls Validate FBDI loads, conversions, external interfaces, data migration, and configurable reports (BIP/OTBI). 5. CSA (Computer Software Assurance) Test Strategy Develop a risk-based test approach aligned to CSA principles. Lead authoring and execution of: PQ (Performance Qualification) tests OQ (Operational Qualification) tests Drive defect tracking, deviation documentation, and retesting closure. 6. Oracle Quarterly Release Impact Validation Conduct Release Impact Assessments for Oracle Cloud patches. Maintain regression test scripts for GxP-relevant processes. Ensure continuous validation and compliance for SaaS updates. 7. Documentation Governance & Audit Preparedness Ensure all documents meet inspection-ready standards for: Health Canada FDA ISO 13485 Support the customer with validation documentation during audits. Train project teams on validation controls and documentation discipline. 8. Cross-Functional Collaboration Work closely with: Trinamix Functional & Technical Architects OIC integration teams Security & Access Control Analysts Customer QA, Regulatory, and Compliance groups Provide validation leadership, guidance, and best practices to all stakeholders. Required Qualifications Education Bachelor’s or Master’s in: Life Sciences Biotechnology Pharmaceutical Sciences Computer Science Quality or Regulatory Science Experience 10–15 years in GxP, CSV, CSA, and regulated system validation. 3+ years validating Oracle Cloud ERP or EBS in a regulated manufacturing environment (SCM/INV/QM/MFG preferred). Demonstrated experience with validation deliverables: SLRA, VP, FRA, TM, PQ/OQ, VSR. Experience with Canadian regulated manufacturers (food, nutraceuticals, CPG, medical devices, pharma) strongly preferred. Proven experience validating integrations, SaaS platforms, and multi-application landscapes. Deep understanding of Oracle Cloud ERP Working experience with OIC, REST/SOAP APIs, BIP, FBDI/ADFDi Experience with Oracle Security Console and audit configuration Familiarity with eDMS/QMS systems (TrackWise, Veeva, MasterControl, etc.) Preferred Qualifications Knowledge of GFSI, GMP for food/nutraceutical manufacturing. ASQ CQA/CQE/CSQE, GAMP 5, or CSV/CSA certifications. Experience in Canadian manufacturing organizations (NPN, Natural Health Products compliance). Location This role is based in Canada, with preference for: Winnipeg / Manitoba (proximity to Vita Health is a plus) Remote work is possible with travel for key workshops or validation milestones. Travel Requirements Occasional travel to Trinamix customer locations (Ontario/Manitoba). Seniority level Mid-Senior level Employment type Full-time Job function Information Technology Ontario, Canada CA$85,000.00-CA$95,000.00 2 weeks ago #J-18808-Ljbffr