SAP Csv

BS or equivalent degree in math, science or engineering
- At least one-year experience in software testing, preferably in FDA-regulated environments
- Familiarity with 21 CFR 11 and Annex 11

Job Requirements will include
- Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met
- Evaluate proposed changes to validated computer systems and recommend level of validation activities required
- Identify and qualify all computer systems which impact cGMP operations using a risk based methodology
- Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
- Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
- Execution of validation plans and validation documents
- Work with overall project manager to include validation activities in implementation timelines
- Ensure 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
- Able to work collaboratively and in a client focused environment
- Be highly motivated, organized, and able to manage priorities
- Have the ability to work with multiple clients and projects
- Have the highest standards for quality, accuracy, and professionalism
- Have excellent communication, presentation, and interpersonal skills
- A complete system life cycle approach as part of a Quality Management System (QMS), from concept to retirement.
- Ability to write Validation plan, Risk assessment, Data management qualification Protocol and report, Operation qualification Protocol and report ,Traceability Matrix ,Validation summary report.
- Coordination 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)
- Understanding of drug development process and working knowledge of FDA, GCP, GLP and GMP requirements.
- Understanding of the principles of computer System Validation.
- Experience in ISO 9001 Software Quality Assurance Methodologies, SEI CMM Models.
- Experience in execution of 1Q/0Q/PQ protocols.
- Experience in Quality/Regulated environment and implementation of Quality Systems for software adhering to ISO 9 standards.
- O 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.Development of requirement guidelines specification documents, design specification documents, project activitie summary documents, trace ability/verification matrix, technical standards documents, Master validation plans for test phases.

**TECHNICAL SKILLS**:

- Operating System: Windows and UNIX.
- Languages: SQL, SQL*Plus, HTML, XML, Java Script, ABAP and TSL
- ERP: SAPS/4HANA
- Development Tools: Visual Basic, Power builder and Developer2000.
- Software Packages: MS Word, Excel, Power Point, Outlook, Frame maker, Internet Services Automated Test Tools: QTP, Quality Center, PVCS Tracker 6.0 & Continuous.Internet Technologies: Internet Basics, HTML&Concepts of Networkings

**Responsibilities**
- Performed end to end validation process for One Pharma project (Blue print to Go-live) in SAP S/4HANA green field ,Brown field and Blue field
- Developed validation Plan for One SAP Project, CSV Risk Assessment, Summary reports and Traceability Matrix.
- Developed validation protocols based on SOP's - IQ, OQ, PQ
- Developed Test Scripts in SAP QM, BW, MM, SD and FI/ Confidential modules.
- Interacted with Functional, Development Team to develop Test Scripts according to the requirements and Business Print Procedure.
- Validated BPP's, URS and FRS as per GMP.
- Involved in Unit Test, Integration, Regression and UAT.

- Using Master date to create data sets for test and validation process.
- Validated RICEF as per BPP specifications.
- Performed pre & post approval reviews for SAP test scripts:

- Reported the defects in HP Quality Center and involved in Regression Testing.
- Conducted Audit trails - 21 CFR part 11 for GMP.
- Involved in Test script development and data validations.
- Used SAP solution Manager and Documentum for document management.
- Tested Reports, interfaces, Conversions, Enhancements and Forms.
- Worked closely with Functional, Development Team to solve the defects reported