Position Details

Job Purpose:
The QA 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 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.

Key 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.
•   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, Change Control and CAPA management systems; Internal/External audits; Customer Complaints; 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.
•   Review and approval of validation protocols/ reports and related documentation to ensure compliance with current EU regulatory expectations and site procedures.
•   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 as applicable.
•   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.

Job Specific Technical, Functional and Professional Competencies:
•   Strong understanding of GMP compliance and quality standards
•   Excellent attention to detail and significant document review experience essential
•   Excellent technical writing skills including deviation reports and SOPs
•   Effective time management and multi-tasking skills
•   Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail
•   Excellent communication skills, both verbal & written.
•   Proficient in written and spoken English
•   Collaborative Team Player

Essential Education and Experience:
•   Third level qualification in relevant science and/or engineering discipline
•   5 years minimum experience working in a in a GMP Quality environment.
•   Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP Regulations.