Description
A major Pharmaceutical company is seeking a Global Validation Project Manager to join their organisation on a permanent basis. The purpose of this opportunity is to participate and coordinate cross-functional teams, being responsible for the execution of major and minor Validation projects.You will be responsible for:
-Manage and lead various best practice projects, including implementing new standards across all sites to provide consistent and improved Validation executions.
-Develop Validation Standard Documents associated with Validation Master Plans, Cleaning Validation Master plans and other identified areas.
-Manage interfaces with key site stakeholders and functional heads to deliver Validation initiatives in accordance with the clients Quality and Regulatory expectations.
-Coordinate and lead progress meetings with the site Validation Directors, Managers, Validation Engineers, and other associated stakeholders.
-Oversee site inspection responses and ensure they are followed up on, tracked, and system improvements are delivered across the network.
Experience/ Education Requirements:
-Degree in Chemical/Process/Mechanical Engineering, or a BA/BS degree in a science related field
-Extensive experience leading Validation project teams, applying and implementing FDA / MHRA cGMP regulations.
-Expert knowledge in validation with a diverse compliance background in cGMP manufacturing.
-Demonstrated experience in interpreting and implementing FDA procedures and practices. Strong experience with Pre-Approval Inspections (or similar FDA site inspections), and demonstrated active participation in the inspection process as a respondent to Validation inquiries.
-Demonstrated matrix management skills and clear ability to work effectively in cross functional team environments. Strong ability to lead global teams in a multicultural matrix environment.
There is significant travel involved throughout and is expected typically 50% - 75%. Offering a competitive remuneration package and the chance to work in a forward thinking dynamic global team this is an opportunity to be taken. Please apply now for further information.