Job Description
Our client, a global healthcare company, iseeks a SAP Validation Consultant, which involves ensuring the compliance, validation, and verification of SAP systems and processes to meet regulatory standards in the healthcare industry. The consultant will collaborate with internal stakeholders to ensure the SAP environment is compliant with industry-specific regulations, providing validation support during system changes, implementations, and upgrades.
This is a remote, contract role, starting with a one-year contract for a 2 year project, that is likely to renew. The selected candidate can be located anywhere in India and must be able to support the client's EST preferred time.
Key Responsibilities :
- Lead the SAP validation process for system changes, upgrades, and implementations, ensuring adherence to healthcare industry standards.
- Work closely with stakeholders to gather validation requirements, document processes, and ensure they align with regulatory guidelines.
- Develop and execute validation plans, protocols, and reports for SAP systems, focusing on system integrity and compliance.
- Provide expert guidance and support during SAP system implementations, including risk assessment, validation strategy, and documentation.
- Ensure proper validation of SAP configurations, including data integrity and audit trails.
- Conduct validation testing (IQ, OQ, PQ) in line with GxP (Good Manufacturing Practices) and 21 CFR Part 11 regulations.
- Collaborate with internal audit and quality teams to review and ensure validation documentation meets company standards.
- Maintain up-to-date knowledge of validation requirements and regulatory changes in the healthcare sector.
- Assist with training internal teams on validation best practices and system compliance
Requirements
Minimum of 4 years of experience in SAP validation in a regulated industry, preferably healthcare or medical equipment manufacturing.Strong knowledge of SAP system configurations and validation processes, including GxP, 21 CFR Part 11, and other industry-specific regulations.Experience in developing and executing validation plans and protocols for SAP solutions.Familiarity with SAP S / 4HANA and its validation requirements.Strong documentation and reporting skills, with a focus on compliance and regulatory documentation.Ability to work independently and manage validation tasks within deadlines.Strong communication skills to engage with both technical and non-technical teams.Knowledge of SAP modules related to validation, such as SAP QM (Quality Management) and SAP PM (Plant Maintenance), is an advantageRequirements
SAP Data Validation