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Duties and Responsibilities:
The incumbent will be responsible for managing Computer Systems Validation (CSV) at the Cincinnati site as well as assisting on regional and global CSV matters. The successful candidate will supervise another employee as well as advise and work closely with project leaders, other IT associates, and Quality regarding GMP computer validation issues. Responsibilities include participating as a project team member on computer system implementation projects, both locally and regionally, to assure that validation activities and life cycle methodology are incorporated and documented appropriately during and after the project in accordance with company standards and procedures. The successful candidate will propose appropriate validation solutions based on a sound understanding of computer system regulations, life cycle development, IT applications and IT infrastructure. The candidate will develop, review and approve computer system validation documentation. Critical job skills include the ability to manage multiple validation projects, to organize documentation, write documentation, to take action in solving problems, and to communicate effectively with employees of various backgrounds and levels in the organization. Requirements:
A minimum of five years of experience with GMP Computer Systems Validation is required, as are demonstrated teamwork, organization, communication and technical writing skills.
Information Technology expertise and experience with IT Infrastructure and IT Application implementations.
Working knowledge of EU & FDA cGMP pharmaceutical regulations, including those that apply to the use of electronic records and electronic signatures
Understanding of GAMP 4 and/or GAMP 5 guidance Education Required:
Bachelor’s degree in information technology, pharmacy, engineering or a related science.
Must be local to the Cincinnati site or willing to relocate without financial assistance from the company.
Qualified candidates are invited to apply through our website (www.patheon.com) by going to the Careers page, then Current Openings, then select USA, Cincinnati Operations. We appreciate your interest; however, only candidates selected for an interview will be contacted. We are not using agencies at this time.
EEO/M/F/D/V
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