Clinical Imaging Research Centre – Head of Quality Assurance / Authorised Person

Head of Quality Assurance / Authorised Person, (2-year Contract)

Description

1. Strategic Quality planning
2. Improving policies and procedure required for human subject safety in compliance with PIC/S GMP/GCP/ISO 9001 
3. Daily release of investigational radiopharmaceuticals
4. Quality Risk Management, Validation Management, Quality Change Management
5. Overseeing Deviation and Out-of-Specification Management
6. Overseeing training and supplier management, contract analysis, environmental monitoring program, handling of recalls/complaints
7. Monitoring the Quality Management for its effectiveness by trending, CAPA, product review, internal/external auditing and management reviews
8. LIMS system implementation
9. Mentoring staff in PIC/S GMP (Good Manufacturing Practice)
10. Leading the Quality Assurance team 
11. Obtaining and maintaining PIC/S GMP certificate by lialsing with the HSA and ISO 9001 certification by liaising with the certifying bod

Qualifications

• 5 years and above experience in applying GMP in a pharmaceutical, health care, or life science environment
• Strong leadership skills
• Experience in establishing cross-departmental quality teams
• Dynamic, positive and open attitude
• Excellent in empowering staff and communication
• Attention to detail
• Minimum qualification of Bachelor Degree preferably in Chemistry, Pharmacy, Life Sciences, Bio-enginnering, Biotechnology, Materials Technology; depend on which is relavent.