SAP CSV Consultant - E2E Implementation (10-12 yrs)

About the Role :

We are seeking a highly experienced and skilled Senior SAP CSV Consultant to join our team.

In this critical role, you will be responsible for ensuring the compliance of SAP implementations with regulatory requirements.

You will lead and execute validation activities across the entire software development lifecycle, from initial design to post-implementation support.

Key Responsibilities :

- Develop comprehensive validation strategies and plans for SAP implementations, upgrades, and modifications.

- Conduct thorough risk assessments, including GMP impact assessments, GAMP category assessments, and ERES applicability assessments.

- Identify and assess potential risks and compliance issues.

- Collaborate with cross-functional teams (IT, Business Process, Quality Assurance) to ensure alignment on validation deliverables and timelines.

Create, execute, and document all validation deliverables, including :

- Functional Design Specifications (FDS)

- Business Design Specifications (BDS)

- Technical Design Specifications (TDS)

- Test Plans and Test Scripts

- IQ/OQ/PQ Protocols

- Traceability Matrices

- Validation Reports

- Release Notifications

- Support defect management and discrepancy investigations.

- Provide guidance and support to project teams on validation best practices and compliance requirements.

- Ensure compliance with relevant regulatory standards (e.g, 21 CFR Part 11, GAMP 5).

- Stay abreast of industry trends, regulatory changes, and best practices related to CSV in SAP.

- Participate in project meetings, training sessions, and governance reviews.

- Prepare status reports and handle escalations effectively.

- Support during client visits and regulatory inspections.

- Contribute to the continuous improvement of validation processes and procedures.

Essential :

- 10+ years of overall experience with a strong focus on SAP CSV validation.

- In-depth knowledge of GAMP 5 guidelines and relevant regulatory requirements.

- Experience in conducting risk assessments, impact analyses, and defining validation scope.

- Strong understanding of SAP implementation methodologies and lifecycles.

- Excellent documentation, communication, and presentation skills.

- Ability to work independently and as part of a team.

- Experience with SAP S/4HANA, SAP ECC, and other SAP modules.

- Experience with validation of integrations between SAP and other systems.

- Knowledge of Quality Management Systems (QMS) and related documentation.

- Experience in the pharmaceutical or life sciences industry