Quality Specialist

Planet Pharma; Liverpool; Hybrid; GBP 40,000 - 70,000

Job description

Contract: 12 Month Contract Initially with the possibility of extension! Full-time

Location: Hybrid with 2.5 days in the office in greater Liverpool area

Company: A Global Biopharmaceutical Company

Job Description:

Justification:

A new position of Quality Specialist has been created to support the External Manufacturing Quality team, due to the insourcing of newly acquired clinical trials.

Job Summary:

The Product Development Quality (PDQ) team, operating under Good Manufacturing Practice (GMP) guidelines, oversees the manufacture, testing, and distribution of clinical supplies (investigational products). This ensures quality and compliance with GMP and other relevant regulations and internal procedures.

Key responsibilities include:

• Drug product batch disposition (release/reject decision)
• Investigational Medicinal Product (IMP) certification and release by the External Manufacturing Quality team
• Auditing of internal GMP systems/processes and suppliers/third-party contractors
• Assisting stakeholders with regulatory advice and preparation for, and management of, regulatory agency inspections
• Prioritizing and aligning the external Qualified Person (QP) release of clinical supplies at Contract Manufacturing Organizations (CMOs)

Qualifications & Experience:

• Degree-qualified or equivalent experience required
• At least 2 years of previous Quality experience, ideally from a pharmaceutical GMP environment
• Project Management/Coordination experience is essential
• Experience with Investigational Medicinal Products (IMPs)
• Strong understanding of QP process and requirements
• Trackwise/Veeva experience is a big plus

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.