Please reply to:- Sadhu, Vibhas / [email protected] / 609-606-9010 Ext.# 1337
Job Details:-
| Job Title : | SAP Validation Engineer |
| Location : | Pennsylvania, PA |
| Expected Duration of Project : | 6 Months |
| Start Date : | 08/11/2014 |
| Interview Type : | Telephonic |
| Duties & Responsibilites : | Job Responsibilities: • Develop a plan for the validation of computer and automation systems ensuring compliance to required regulatory requirements. • Partner with the Global IT Compliance organization to gain in-depth understanding of guidelines, requirements and general expectations related to Computer Systems Validation and Compliance • Deliver validation activities in compliance with US and EU regulations. • Participate in the design of systems and equipment, if needed, to ensure that they comply with GMP/GCP/GLP requirements. • Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports. • Initiate and implement change control activities in accordance with site procedures. • Compile and analyze validation data and make recommendations for improvements. • Participate on cross-functional project teams with the support of Validation activities. • Author relevant validation documentation (e.g. Master Plans, Test Scripts, Templates, etc.), as defined by the Client's IT SDLC methodology. • Execute all relevant validation protocols and test procedures, as defined by the Clients' IT SDLC methodology • Develop validation documentation as required• Execute qualification protocols as required. • Prepare reports of executed protocols for review by QA. • Track and resolve exceptions during qualification activities. • Proactively resolve conflicts between compliance requirements and project/business constraints. • Co-ordinate validation activities with other IT, Business, and QA activities. Skills and Experience Required: • 4-6 Years previous experience in SAP Validation. • Knowledge of GMP/GCP/GLP requirements • Knowledge of US and EU regulations • Good documentation skills • Ability to work with various teams/departments • Good understanding of SDLC methodolgy |
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