Position Details

The QA Validation Specialist will be responsible for delivery of Quality Assurance activities to ensure product is manufactured in accordance with GMP and Regulatory requirements. The role will also include the review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing.

This role will be a key member of the Quality Assurance team, providing hands-on technical support and oversight for validation activities at the manufacturing facility. This role is essential in ensuring that processes and equipment are validated and qualified according to industry regulations while guiding the implementation of the Site Validation Master Plan. This key role is an individual contributor role whereby the individual must be a self-starter with professional and academic experience in QA and Validation activities. This key role must ensure effective interaction with other departments such as Quality Control, Manufacturing, Engineering and Technical Services.
 

RESPONSIBILITIES

• Site QA point of contact providing technical expertise, feedback and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction and manufacturing and assist in the resolution of issues commensurate with the level of risk.
• Review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing.
• Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.
• QMS areas of responsibility include Deviation investigations, Change Control and CAPA management systems; Internal/External audits; Vendor Management; review /approval Manufacturing Batch Records and assessment /approval of production materials.
• Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility.
• Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
• Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines.
• Ensure application of Quality Risk Management principles including the application of risk assessment tools such as FMEA
• Act as the QA lead in QA activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering, and others.
• Actively contribute to continuous improvement activities.
• Other duties as assigned.

 EDUCATION /EXPERIENCE

• Third level qualification in relevant science and/or engineering discipline
• 5 years minimum experience working in a in a GMP Quality environment providing QA technical support and oversight to validation and qualification activities 
• Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP Regulations

Core Competences

• Strong understanding of GMP compliance and quality standards
• In-depth knowledge of quality management system (QMS) procedures and technical documentation
• Excellent analytical, problem-solving, and decision-making skills
• Excellent attention to detail and significant document review experience essential
• Excellent technical writing skills including deviation reports and SOPs
• Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail