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 involve providing direct quality support to Operations at the facility.

The role will include the review and approval of batch related documentation and activities related to on-going manufacturing including the completion of root cause investigations of non-conformances, approving manufacturing related change controls and the implementation of process improvements. 

This key role is an individual contributor role whereby the individual must be a self-starter with professional and academic experience in Quality Assurance. This key role must ensure effective interaction with other departments such as Quality Control, Manufacturing, Engineering and Technical Services.

Key Responsibilities:

•    QMS areas of responsibility include Deviation Investigations, Change Control and CAPA management systems; performing Internal Audits; assessing Customer Complaints; Vendor Management and supporting External audits
•    Review /approval of Manufacturing Batch Records
•    Assessment /approval of production materials including APIs, excipients, primary and secondary packaging 
•    QA point of contact for Operations providing technical expertise, feedback and guidance for QA and compliance topics /issues including manufacturing, validations, new product introduction 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
•    Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility
•    Review / approval of Quality Control testing 
•    Ensure schedules for review and approval of GMP /batch related documents are maintained to support batch release, 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 Operations 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:
•    Proven ability to work effectively on their own initiative as well as effectively contributing to the team environment
•    In-depth knowledge of quality management system (QMS) procedures
•    Strong understanding of GMP compliance and quality standards
•    Strong Experience of using electronic and physical documentation systems
•    Excellent attention to detail and significant document review experience essential
•    Excellent technical writing skills including deviation investigation 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
•    In-depth knowledge of Quality Management System (QMS) procedures
•    5 years minimum experience working in a GMP Quality environment
•    Experience in a Quality function with strong knowledge of batch related documentation and activities related to on-going manufacturing including the completion of root cause investigations, change controls and the implementation of process improvements