Job Description :
JOB DESCRIPTION
SAP Quality Assurance and Validation Analyst:
To manage and ensure that the project schedules are adhered to as per the client specifications and deliveries are as per the time and quality standards.
Should require Hands on experience in Validation of SAP modules. Non- product software validation.
Good Understanding of FDA (21 CFR Part 210 & 211, 21 CFR Part 11) and GAMP guidelines applicable to computer system validation.
Authoring/executing Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports as per the compliance requirements.
Knowledge of HPQC and SAP testing Validation ; not SAP testers • Candidate should possess excellent verbal and written communication skills.
Requirements:
Bachelor''s degree in computer science, computer engineering, life science, or any other relevant degree.
Minimum of 5 years professional experience in medical devices or pharma computer systems validation OR in computer systems quality assurance (medical device and/or consulting background
Technical proficiency with the Microsoft Office suite of tools required, especially Microsoft Word and Excel is required.
Experience with a Validation of GxP applications is required