CSV Consultant

Proclinical is pleased to advertise an exciting vacancy for a CSV Consultant to join a medical technology company that is committed to defend against time-sensitive situations by providing medical countermeasures to more than 30 countries around the world.

Located in Missouri, the CSV Consultant will take direction from a Team Leader to support and enhance the quality and compliance operations posture for the company's IT department. This will include authoring solution development lifecycle documents (SDLC), including user requirement specifications, detailed design, and configuration specifications, test plans, test cases, test strategies, change control, and decommissioning plans. The CSV Consultant will also assist in continuous quality systems improvement for this local IT department that interfaces between a set of local site pharma/device manufacturing quality standards and a set of global IT quality standards. This is a contract role.

Job Responsibilities:

• Providing technical and compliance expertise to write SDLC documentation in accordance with local procedures, templates, regulatory requirements (21 CFR Part 11, 211, 820) and IT Security Standards.
• Tracking and executing computer systems Periodic Reviews, User Account Reviews, and other computer system compliance processes as assigned.
• Providing technical and compliance expertise to support the continuous improvement of BT departmental operating procedures and processes.
• Assisting in performing change, controlling impact assessments, and working with technical subject matter experts (SMEs).
• Representing the company's IT department in site level change control meetings.

Skills and Requirements:

• Demonstrable experience with CSV.
• Experience in authoring solution development lifecycle documents.
• Excellent communication, presentation, persuasion, and client facing skills.
• Excellent English written and oral skills.
• Experience working in a consulting environment preferred.

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 Keri Marshall on +44 207 440 0679 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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