QA Officer - Dev & Preclinical

Job Summary

Product Development Quality (PDQ) Good Manufacturing Practice (GMP) serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with GMP and other applicable regulations and internal procedures.

Key Responsibilities

• Drug product batch disposition (release/reject decision).
• Investigation Medicinal Product Certification and release by the External Manufacturing Quality.
• Audit of internal GMP systems/processes and suppliers/third party contractors.
• Assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections.

Description

• Serves as Project Manager for prioritizing and alignment of external Qualified Person (QP) release of clinical supplies at Contract Manufacturing Organisations (CMOs).
• Partner with Regulatory Affairs and Global Clinical Supply Chain to ensure on-time delivery of Health Authority approvals for release of clinical supplies (as applicable).

Desired Characteristics:

• Ability to understand the needs of the business and commitment to deliver efficiency.
• Able to collaborate across multiple teams.
• Excellent communication skills.
• Innovative and inquisitive nature to ask questions.
• Ability to learn new tools and processes.
• Excellent organisation and time management skills.

Qualifications & Experience

• Degree qualified or equivalent experience required.
• Project Management experience is essential.
• Previous Pharmaceutical Quality experience is desired/preferred.

Please note: this is a 12 month contract