For one of our Pharma Clients in the we are looking for Validation Specialist, to Join their Team for an Initial 6 Months contract (Please note that Fluency in FRENCH is a must!!!).
Major Accountabilities would include:
Design, Author, and Execute Computerized System Validation (CSV) - according to GAMP 5 guidance - especially on Analytical Laboratory Test Equipment and other Lab Information Systems
Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
Translate technical information and requirements into qualification/validation test design
At least 3-5 years of pharmaceutical of FDA related validation experience
Good knowledge of GMPs, 21CFR Part 11, USP 1058 - and other relevant industry regulations and guidance
Excellent written and oral communication skills - especially on technical topics
Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project
Experience with a multitude of laboratory equipment a plus
Please forward your CV to Karim.firstname.lastname@example.org . We can only consider individuals eligible to work in CH or EU
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