SAP CSV

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

Heres how youll contribute:

You should have BS or equivalent degree in math science or engineering
At least oneyear experience in software testing preferably in FDAregulated environments
Familiarity with 21 CFR 11 and Annex 11
You ll do this by:
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 activities summary documents trace ability/verification matrix technical standards documents Master validation plans for test phases.

Technical Skills required to contribute:
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 Networking

Responsibilities

Performed end to end validation process for One Pharma project (Blue print to Golive) in SAP S/4HANA
Developed validation Plan for One SAP Project CSV Risk Assessment Summary reports and Traceability Matrix.
Developed validation protocols based on SOPs 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 BPPs 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 in Test Director.
Validated QTP for test automation.

Remote Work :

No