Computer System Validation

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Employer - PharmEng Technology
Job Description

Computer System Validation- ERP System

PharmEng Technology is currently seeking a Computer System Validation- ERP System to assist our team for projects in Toronto, ON. The position is available immediately conditional of a successful interview.

Job Description Consultant with knowledge of ERP and inventory software Develop validation protocols Review execute test scrip Develop URS, FS Write validation reports Prepare for upcoming HC audit Develop and execute computerized systems validation protocols (IQ/OQ/PQ). Validation Summary report, Data Transfer and Integrity Testing Protocol. Prepare validation documents: capture functional requirements for the client, change control, standard operating procedures (SOPs) and reports etc. Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control etc. Maintain personal training records. Ensure compliance with relevant regulations (e.g. cGMP/GLP/GAMP/GALP). Complete assigned projects and tasks within agreed deadlines. Assessment of client computer systems in terms of FDA 21CFR Part 11 compliance Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects System Implementation ERP SAP Project Management methodology
Job Requirements: Recommended) Bachelor Degree and 3-5 years of validation experience or Masters Degree and 2-5 years of validation experience and biotechnology experience. Experience with SAP: SAP products, SDLC, ERP (Enterprise Resource Planning), Familiarity with applicable US and worldwide regulatory requirements for the biotechnology industry (i.e. GMP and GLP). Experience with Microsoft Word and Excel. Willingness to travel Hold a valid driving license and passport Must be able to legally work in Canada/USA
Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.

Location - Canada
Date Posted - 27 Jun 2019
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