It Validation Consultant

A commercial-stage biopharmaceutical company is seeking to recruit an IT Validation Consultant to their office in Greater Boston. The company focuses on the discovery and development of precision genetic medicine to treat rare diseases. This vacancy is an exciting opportunity to work with a company that provides precision genetic medicine and boasts a portfolio of treatments for a range of issues, including muscular dystrophy and other disorders.

Job Responsibilities:

• Ensuring GxP computerized systems are validated and controlled in compliance with local and international guidelines.
• Reviewing and approving SDLC documentation including sops, qualification, protocols, gap assessments, risk assessments, user requirements.
• Overseeing CSV related change controls, deviations, and investigations.
• Providing regulatory guidance for csv policies and procedures for validation and data integrity.

Skills and Requirements:

• Demonstrable experience with GxP.
• Demonstrable experience in a similar or comparable role.
• Degree educated preferred.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

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 contact Jack Coyle at +1 312-488-2969 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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