Summary: An experienced Quality Auditor / Quality Specialist is sought to join a Global Development Quality function on a contract basis. The role involves ensuring the quality, compliance, and release of clinical trial materials across a range of investigational medicinal products. The successful candidate will conduct audits, review documentation, and collaborate with stakeholders to maintain high standards in pharmaceutical quality assurance. This position is critical in supporting the delivery of safe and effective medicines to patients.
Key Responsibilities:
- Perform final review of clinical batch records to ensure compliance with GMP requirements and alignment with regulatory submissions
- Compile, review, and approve clinical supply data packs for presentation to the Qualified Person (QP) for final release
- Conduct routine audits of data, documentation, procedures, systems (including computer systems), equipment, and facilities
- Review and approve production and analytical documentation supporting API, Safety Assessment, and clinical supply lots (bulk and packaged)
- Ensure compliance with company SOPs, GMP standards, and global regulatory requirements
- Perform audits and inspections independently or as part of a team
- Document audit findings, prepare reports, and work with stakeholders to define and implement corrective actions
- Communicate and resolve audit observations with internal teams
- Escalate inspection outcomes and quality risks to appropriate management
- Collaborate with global clinical supply chain and manufacturing partners
Key Skills:
- Experience within the pharmaceutical industry or a drug regulatory authority, with a solid working knowledge of cGMP regulations
- Strong attention to detail and high standards of documentation accuracy
- Excellent written and verbal communication skills
- Self-motivated with the ability to work confidently with minimal supervision
- Strong organisational skills with the ability to manage multiple priorities
- Effective problem-solving and decision-making capabilities
- Proficient in Microsoft Office and able to learn GMP-related systems and tools
- Bachelor’s degree in Life Sciences or a related scientific discipline
- Minimum of 3 years’ experience in Quality roles within the pharmaceutical industry
Salary (Rate): undetermined
City: London Area
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
An exciting opportunity is available for an experienced Quality Auditor / Quality Specialist to join a Global Development Quality function on a contract basis. This role provides exposure to a broad range of investigational medicinal products, from small molecules through to complex biologics and immunotherapies. You will play a critical role in ensuring the quality, compliance, and release of clinical trial materials, directly supporting the delivery of safe and effective medicines to patients.
Key Responsibilities
- Perform final review of clinical batch records to ensure compliance with GMP requirements and alignment with regulatory submissions
- Compile, review, and approve clinical supply data packs for presentation to the Qualified Person (QP) for final release
- Conduct routine audits of data, documentation, procedures, systems (including computer systems), equipment, and facilities
- Review and approve production and analytical documentation supporting API, Safety Assessment, and clinical supply lots (bulk and packaged)
- Ensure compliance with company SOPs, GMP standards, and global regulatory requirements
- Perform audits and inspections independently or as part of a team
- Document audit findings, prepare reports, and work with stakeholders to define and implement corrective actions
- Communicate and resolve audit observations with internal teams
- Escalate inspection outcomes and quality risks to appropriate management
- Collaborate with global clinical supply chain and manufacturing partners
Experience, Knowledge & Skills
- Experience within the pharmaceutical industry or a drug regulatory authority , with a solid working knowledge of cGMP regulations
- Strong attention to detail and high standards of documentation accuracy
- Excellent written and verbal communication skills
- Self-motivated with the ability to work confidently with minimal supervision
- Strong organisational skills with the ability to manage multiple priorities
- Effective problem-solving and decision-making capabilities
- Proficient in Microsoft Office and able to learn GMP-related systems and tools
- Qualifications
- Bachelor’s degree in Life Sciences or a related scientific discipline
- Minimum of 3 years’ experience in Quality roles within the pharmaceutical industry
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.
