This process-oriented QA training and focused role requires excellent communication skills and quality expertise. This position will be responsible for establishing and implementing a GxP training program for all employees.
Establish and implement a Global training program.
Maintain and improve the training program. Ensure the global training program is extended to GXP operations. Work with all departments supporting GXP operations to establish departmental training matrices.
Implement and maintain a validated electronic training system compliant with regulatory, and quality requirements.
Provide new hires an introduction to Quality System as part of New Employee Orientation.
Create and deliver GXP training events.
Maintain a validated electronic training management system compliant with regulatory, and quality requirements.
Collaborate with cross-functional departments to ensure timely documentation of training.
Supports audits (internal, external, third party) in order to verify that regulatory and quality requirements have been met
Well-organized and detailed oriented professional, with strong verbal and written communication skills.
Advanced computer skills with working knowledge of MS office such as Word and Excel, Access, Adobe Acrobat professional, and SharePoint.
Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet production deadlines.
Experience with electronic quality management system and electronic signatures is required
Bachelor’s degree in scientific discipline is required; 8+ years of experience in pharmaceutical industry; with 5+ years of experience in managing document management function and an electronic document management system such as Documentum, Master Control or equivalent