SAP CSV Consultant

Company : Zensar

Location : Hyderabad, India

Experience : 8-12 Years

Employment Type : Full-time

Job Overview :

Welcome to Zensar! We are seeking an experienced SAP CSV Consultant with 8 to 12 years of experience in SAP ECC and S/4 HANA implementation, support, and rollout projects, specifically within a regulated environment. This role is crucial for ensuring the validation and compliance of computer systems, particularly adhering to FDA regulations like 21 CFR Part 11 and Annex 11. You will be instrumental in the end-to-end validation process, from planning and protocol development to execution, reporting, and defect management, all while maintaining the highest standards of quality and professionalism.

Key Contributions and Responsibilities

Validation Planning & Execution :

- Assist with the development of system requirements and specifications, ensuring testability and compliance with 21 CFR Part 11.

- Evaluate proposed changes to validated computer systems and recommend the appropriate level of validation activities.

- Identify and qualify all computer systems impacting cGMP operations using a risk-based methodology.

- Develop comprehensive CFR Part 11 computer systems validation plans, qualification test protocols (IQ/OQ/PQ), traceability matrices, and validation reports.

- Develop and maintain test plans, test scripts, and user acceptance tests (UAT), managing their execution.

- Coordinate with the overall project manager to integrate validation activities into implementation timelines.

- Perform end-to-end validation processes for projects in SAP S/4HANA, from blueprint to Go-Live.

- Developed validation protocols based on SOPs - IQ, OQ, PQ.

- Developed Test Scripts in SAP QM, BW, MM, SD, and FI/CO modules.

- Involved in Unit Test, Integration, Regression, and UAT.

- Used Master data to create data sets for test and validation process.

- Validated RICEF (Reports, Interfaces, Conversions, Enhancements, Forms) as per BPP specifications.

- Performed pre & post-approval reviews for SAP test scripts.

Compliance & Quality Assurance :

- Ensure the initiation, preparation, and closeout of all CSV related deviations, discrepancies, and change control documents.

- Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems.

- Conducted Audit trails - 21 CFR Part 11 for GMP.

- Validated BPP's, URS and FRS as per GMP.

- Experience in ISO 9001 Software Quality Assurance Methodologies, SEI CMM Models.

- Implementation of quality systems in line with SDLC requirements and developing Validation Risk Assessment plan Summary Reports.

- Participation in implementation of 21 CFR Part 11 - Electronic Record and Electronic Signature requirements, Securi trail (user and date time stamps), Validation, Development Methodologies, Requirements, Design, Testing Methodo UT/IT/UAT phases.

- Participation in creation of SOPs, Validation Plans, and software inspection/audits.

Collaboration & Problem Solving :

- Work collaboratively in a client-focused environment, demonstrating high motivation and organizational skills.

- Able to manage priorities effectively and work with multiple clients and projects.

- Have the highest standards for quality, accuracy, and professionalism.

- Excellent communication, presentation, and interpersonal skills.

- Coordinate with business, implementation team, QA, and Client CSV team.

- Identifying opportunities for process and system improvements based on periodic review, root cause analysis, and

corrective and preventative actions (CAPA).

- Work closely with Functional, Development Team to solve the defects reported in Test Director.

Documentation & Reporting :

- Develop requirement guidelines specification documents, design specification documents, project activities summary documents, traceability/verification matrix, technical standards documents, Master validation plans for test phases.

- Reported the defects in HP Quality Center and involved in Regression Testing.

- Used SAP solution Manager and Documentum for document management.

- Tested Reports, interfaces, Conversions, Enhancements and Forms.

Required Qualifications and Technical Skills

Experience :

- 8 to 12 years of SAP CSV experience in ECC and S/4 HANA implementation, support, and rollout projects.

- At least one-year experience in software testing, preferably in FDA-regulated environments.

- Experience in execution of IQ/OQ/PQ protocols.

- Experience in Quality/Regulated environment and implementation of Quality Systems for software adhering to ISO 9 standards.

Education :

- BS or equivalent degree in Math, Science, or Engineering.

Domain Knowledge :

- Familiarity with 21 CFR Part 11 and Annex 11.

- Understanding of drug development process and working knowledge of FDA, GCP, GLP, and GMP requirements.

- Understanding of the principles of Computer System Validation (CSV).

1. Operating Systems : Windows and UNIX.

2. Languages : SQL, SQL-Plus, HTML, XML, JavaScript, ABAP, and TSL.

3. ERP : SAP S/4HANA and ECC.

4. Development Tools : Visual Basic, Power Builder, and Developer2000.

5. Software Packages : MS Word, Excel, PowerPoint, Outlook, Frame Maker, Internet Services.

6. Automated Test Tools : QTP, Quality Center, PVCS Tracker 6.0 & Continuous.

7. Internet Technologies : Internet Basics, HTML & Concepts of Networking.

Soft Skills : Highly motivated, organized, ability to manage priorities, work with multiple clients/projects, highest standards for quality/accuracy/professionalism, excellent communication/presentation/interpersonal skills, and a complete system life cycle approach as part of a Quality Management System (QMS).