SAP Validation SME- IT CSV

Job summary

Create, review, and approve or acknowledge validation deliverables for SAP systems and data migration projects. Apply risk management, testing, audit, and quality assurance practices to help ensure IT projects meet pharmaceutical quality and regulatory requirements.

Job details

We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation/Computerized System Assurance, Risk Management, Test Management and Audits. Below are the role expectations: 5 – 10 years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry. Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5. Experience creating, reviewing, and approving / acknowledging validation deliverables. Strong knowledge of Software Development Life Cycle (SDLC), testing methodologies, risk-based testing, requirement traceability, defect lifecycle management, and quality assurance processes, with the ability to analyze business and functional requirements and identify quality risks. Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements. Experience with validation of SAP system and data migration projects is mandatory Thorough Knowledge in compliance and validation concepts. (Change, Deviation, Supplier management) Knowledge of validation tools and templates used in the pharmaceutical industry. Example: HP ALM, Documentum, Veeva and ServiceNow.

What you’ll do

Create, review, and approve or acknowledge validation deliverables for SAP systems and data migration projects. Apply risk management, testing, audit, and quality assurance practices to help ensure IT projects meet pharmaceutical quality and regulatory requirements.

Requirements

Requires 5–10 years of Life Sciences industry experience, strong knowledge of pharmaceutical regulations and validation concepts, and mandatory experience validating SAP systems and data migration projects. Candidates should understand SDLC, testing and risk management processes, quality requirements, and industry tools such as HP ALM, Documentum, Veeva, and ServiceNow.

Listed skills

• Quality assurance · Preferred
• Risk Management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Computerized System Validation
• Computerized System Assurance
• Risk Management
• Test Management
• Audits
• Pharmaceutical Compliance
• 21 CFR Part 11
• GxP
• GAMP 5
• Validation Documentation
• Software Development Life Cycle
• Risk-Based Testing
• Requirements Traceability
• Defect Lifecycle Management
• Quality Assurance
• SAP Validation

Job areas

• Technology
• Consulting
• Healthcare
• Management & Leadership

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