Essential Duties & Responsibilities: |
• Responsible for authoring portions of regulatory submissions and defending the commissioning, design, and qualification of GMP, GLP equipment to regulatory agency representatives during inspections |
• Develop and approve cGMP documents including, but not limited to, Master Validation Plans, Protocols, SOPs |
• Leading and Managing projects for the validation equipment, processes, and products and to perform risk assessments to ensure compliance to all safety, quality, regulatory and operational requirements |
• Review of equipment specification/design/procurement/installation and validation |
• Project planning and execution including scheduling, task management, milestone planning and reporting |
• Generation, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures |
• Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQOQ, etc.) |
• Employee will be required to develop an in-house training and competency courses for all grades of validation technicians |
• Maintaining the validation tracking program, assessing the requirements for routine validation, revalidation and coordinating validation projects |
• Actively support internal and contract research and development to scale and product transfer qualification and provide feedback internally |
• FDA and Contract client liaison in presentation of validation programs and documentation |