Clinical Compliance Specialist

Job Responsibilities: 

• To provide QA support for work performed at contract manufacturers and analytical laboratories for primarily for developmental/clinical use. 

• To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP. 

• To perform GMP release of IMP and ensure compliant release to other global markets as appropriate.

• To communicate with contractors/suppliers regarding technical information and queries. 

• Ensure deviations/OOS are adequately investigated and documented. 

• Ensure clinical complaints are adequately investigated and reported. 

• To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP and IND/CTA requirements. 

• Review and approve Master records, labels and protocols. 

• Actively participate in project meetings as required.