QA Specialist

Position Details

The QA Specialist will be responsible for delivery of QA 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.

This role will work on a permanent evening shift from 14:00 to 22:30pm.

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