SAP CSV Consultant - E2E Implementation (4-6 yrs)

Job Description :

Key Responsibilities :

- Lead and execute end-to-end CSV activities for SAP implementations, including risk assessments, gap analysis, and the development and execution of validation protocols.

- Champion full lifecycle validation for all applicable computer systems, ensuring they are designed, validated, operated, and retired in compliance with GxP regulations and computer system validation (CSV) guidance.

- Validate manufacturing, laboratory, and other business systems within the SAP ecosystem.

- Collaborate with project teams to compile user requirements for local and group software systems.

- Conduct risk assessments and periodic reviews throughout system lifecycles to ensure systems are maintained in a validated state during their operational life.

- Utilize quality risk management principles to deliver scalable and efficient CSV approaches.

- Authorize validation plan deliverables and CSV SOPs/policies.

- Develop and execute test plans/scripts and conduct documented black box testing throughout system lifecycles.

- Participate in Performance Qualification (PQ) and User Acceptance Testing (UAT), ensuring appropriate documentation of testing is performed.

- Collaborate with system vendors to leverage appropriate information and documentation into Sterling CSV activities.

- Compile and maintain accurate CSV documentation, ensuring full traceability throughout system lifecycles.

- Stay abreast of evolving GxP regulations and industry best practices related to CSV.

Qualifications & Experience :

- 4-6 years of experience in Computer System Validation (CSV) within a regulated industry (Pharmaceutical preferred).

- 2-3 full lifecycle end-to-end SAP implementations.

- Strong understanding of GxP regulations (e.g., 21 CFR Part 11, EU Annex 11) and industry best practices for

CSV.

- Experience with SAP validation methodologies and tools.

- Proven ability to author and execute validation protocols, including IQ/OQ/PQ.

- Experience in conducting risk assessments and developing risk mitigation strategies.

- Excellent written and verbal communication, presentation, and interpersonal skills.

- Strong analytical and problem-solving skills.

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

- Experience with quality risk management principles.

- Proficiency in Microsoft Office Suite.

Preferred Skills :

- Experience with SAP modules such as SAP ERP, SAP S/4HANA, and SAP ECC.

- Knowledge of industry standards such as GAMP 5.