CSV Consultant job in St. Louis, Missouri

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This vacancy has now expired. Please see similar roles below...

Proclinical has teamed up with a market leading biotech know for is Scientific and operational excellence which discovers, invents, develops and manufactures medicines that treat serious medical conditions. They are an established company who have a global presence but are growing rapidly due to a healthy pipeline of new medicines.

This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Specialists

Job Responsibilities:

To support and enhance the quality and compliance operations with respect to Data Integrity. This includes assisting with ensuring systems meet data integrity requirements (ALCOA and 21 CFR Part 11).
Assist with the authoring of solution development lifecycle documents (SDLC) including standard operating procedures, user requirements specifications, detailed design and configuration specifications, test plan, test cases, test strategy, change control, and decommissioning plans.
Assist in continuous quality systems improvement for the Quality Compliance department that interfaces between a set of local site combination product manufacturing quality standards
Work on operations support (User Account Reviews, Periodic System Reviews, Change Controls) and projects support for these types of systems: laboratory, manufacturing, environmental, quality support, configuration management

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Joseph Emmott on +44 203 8141 316 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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