GLP QA Auditor – Regulatory Compliance Lead

Smithers Group; Harrogate; Hybride; GBP 32 000 - 48 000; Plein temps

Avantages offerts par ce poste

private healthcare

employer matched pension contributions

free mortgage advice service

25 days annual leave plus Bank Holiday

eyecare vouchers

Ride2Work scheme

Résumé du poste

Smithers Environmental Risk Sciences (ERS) Ltd. is seeking a Quality Assurance (QA) Officer to join our on-site QA team in Harrogate. The role focuses on ensuring GLP-compliant practices across protocols, data, and reports within a fast-paced contract research environment.

You will conduct internal audits, report findings, and support regulatory inspections while providing training on quality systems to operations staff. This full-time, 37-hour week position offers development in a global CRO.

Qualifications

• Bachelor of Science/Arts (BSc/BA) degree; degree in a science field is preferred.
• Strong Quality Assurance experience, preferably in GLP or a proven work history in a regulatory environment working to GLP.
• Comprehensive knowledge of, and the ability to interpret, MHRA/OECD GLP Regulations
• Good writing, numeracy and computer skills.
• Excellent communication skills, with the ability to work well with people at all levels of the Organisation.
• Possess excellent organisational skills.
• The ability to identify opportunities for improvement and drive to successful implementation.
• Experience of CSV auditing and the ability to train others, in a range of QA related activities, would also be advantageous.

Responsabilités

• Conduct audits of protocols, data, reports, and processes to verify compliance with GLP, internal SOPs, and applicable regulatory guidelines (e.g. MHRA, OECD).
• Accurately and concisely report audit findings to laboratory personnel and management.
• Participate in facility, process, and computer system audits to ensure ongoing compliance and identify areas for improvement.
• Maintain QA audit schedules, training records, and controlled documents.
• Communicate effectively (verbal and written) when interacting with staff members.
• Assist in preparing for and supporting sponsor, and regulatory inspections.
• Provide training to operations staff in the areas of quality systems procedures (SOPs) and regulatory compliance.
• Additional duties as assigned.

Connaissances

QA Experience

GLP Knowledge

Regulatory Compliance

Audit Reporting

Communication Skills

Training & Mentoring

Formation

Bachelor of Science in science

Outils

CSV Auditing

Description du poste

Smithers Environmental Risk Sciences (ERS) Ltd. is seeking a Quality Assurance (QA) Officer to join our on-site QA team in Harrogate. The role focuses on ensuring GLP-compliant practices across protocols, data, and reports within a fast-paced contract research environment.

You will conduct internal audits, report findings, and support regulatory inspections while providing training on quality systems to operations staff. This full-time, 37-hour week position offers development in a global CRO.