Job
Description
Candidates must have 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 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. Coordination with business ,Implementation team ,Client CSV and Client QA team.
