Principal Consultant – SAP S​/HANA Validation Lead; Life Sciences

We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation for ERP applications like ECC/SAP S/4 HANA, Cloud Validation, Risk management and Quality Management. The candidate will have to perform validation service activities related to ECC to SAP S/4 HANA transformation or SAP implementation program.

• Own and drive CSV activities for SAP ECC to SAP S/4
  
  HANA transformation programs and new SAP implementations.
• Develop and execute validation strategies, plans, protocols, and reports for GxP and non-GxP systems.
• Ensure validation activities comply with regulatory and company quality requirements.

• Define validation frameworks and lifecycle methodologies for SAP S/4
  
  HANA programs.
• Conduct system risk assessments and determine validation scope.
• Implement risk-based testing approaches aligned with GAMP 5 and industry best practices.

• Ensure compliance with 21 CFR Part 11, GxP Regulations, GAMP 5, Data Integrity requirements, Data Privacy regulations, Information Security standards and SOX IT controls
• Support audit readiness and inspection preparedness.
• Create, review, approve, and maintain-Validation Plans (VP), User Requirements Specifications (URS), Functional & Design Specifications, Risk Assessments, IQ/OQ/PQ documents, Traceability Matrices, Validation Summary Reports (VSR) and SOPs and related quality documents

• Collaborate with client Quality, Compliance, and Validation teams.
• Ensure systems comply with internal policies and health authority requirements.
• Recommend process improvements and updates to CSV procedures and SOPs.

• Work closely with SAP functional and technical teams across modules such as:
  Finance (FI/CO), Supply Chain, Manufacturing, Procurement, Quality Management and Master Data Governance (MDG)
• Assess validation impact of system configuration, enhancements, interfaces, and data migration activities.

Minimum of 12+ years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.

Experience creating, reviewing and approving / acknowledging validation deliverables.

Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements

Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, SOX IT, Cloud, S4, Data Privacy, Data Integrity and Information Security

Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of SAP S4 HANA, considering GxP & Non GxP elements and recommend for risk-based testing approach as required.

Work with the Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvements plan to streamline practices, and revise CSV related SOPs as necessary.

Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.

Knowledge on basic function on SAP work streams/modules

Knowledge of various tools/applications used in SAP implementation program Like Solution Manager, CHARM, SAP GRC, DRC, SAP MDG, SAP Rise, Data migration tool (SNP, ADM etc.)

Successful track record using Lean/Agile approaches to validate assets

Provide leadership in critical engagements and drive successful outcomes

• Candidates…