A vacancy has arisen for the position of Quality Assurance Manager with ILC Therapeutics at BioCity.

Summary

The QA Manager shall be responsible for the implementation of the Quality Management System, working with colleagues to ensure compliance with the QMS and with relevant GxP requirements and standards.
The QA Manager will have a breadth of knowledge in clinical research, GCP and an understanding of the principles of GMP regulations that will apply to ILC vendors.

Responsibilities

• Including but not be limited to:
• Day-to-day management of the Quality Management System
• Issue of GxP documentation as required
• Advising and supporting contract manufacturing sites in GMP compliance in relation to the IMP registered documentation
• Review of Manufacturing and Analytical Testing records from third-party manufacturing sites as required
• Management of Deviations; support investigations as appropriate (internal and external)and closure
• Ensure a GCP training programme is in place for all relevant employees
• Coordination of Change Control, Deviation and CAPA management
• Batch Release support in alignment with the Qualified Person (QP)
• Review of Technical Agreements with suppliers
• Manage the creation, processing and review of GxP risk assessments as assigned
• Support the performance of internal and external audits to determine compliance with the QMS and with GxP standards and identify areas of improvement
• Support the review, approval and ongoing management of critical suppliers, contract manufacturers and providers of other GxP related outsourced activities
• Support the development and implementation quality related procedures and policies and deliver training to staff
• Support the review and approval of Standard Operating Procedures (SOPs), forms, product specifications and any other quality related documentation relating to IMP manufacture
• Keeping up to date with current industry practices, applicable quality legislation and industry news.
• May assume line management supervision and mentoring responsibilities to junior employees
• Maintaining good working relationships with company colleagues at all times
• Contributing to improving ILC processes and promoting effective change

Competencies

• Good knowledge of Good Clinical Practice (GCP) and/or other applicable regulatory requirements
• Dedication to quality and reliability in all work tasks
• Must read, write and speak fluent English
• Able to demonstrate effective communication of relevant information to both senior management and colleagues
• Functions independently with little or no supervision
• Self-motivation, eagerness to grow professionally and commitment to self-development
• Working knowledge of Microsoft Word, Excel and PowerPoint

Education and Experience

• Honours Degree in a life sciences
• Three-plus years of appropriate GCP and GMP Quality Assurance experience
• A minimum of five years’ industry experience, with demonstrable knowledge of working within a regulated scientific research environment
• Experience in document control and administration of a Quality Management System Experience and knowledge in investigational techniques
• Experience and knowledge In Quality Risk Management and Risk Assessment

Desirable

Recognised auditing qualification

Please send your application and CV to: [email protected]