Quality Auditor

Salary: £31.08 per hour

Based in Moorgate, London, our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and health products. They have an exciting opportunity for a Quality Auditor to join the team within Development Quality and who will be involved in supporting the GMP Quality Assurance activities at the London site. The role is a temporary contract initially signed off 6 months with a possible extension and offers hybrid working and an hourly rate of up to £31.08per hour, depending on experience.

Responsibilities:

Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements. In addition, the Auditor communicates and resolves audit comments with client areas. Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards. Issue reports summarizing deficiencies and work with areas to execute remedial action. Notify appropriate management of inspection result.

Key Result Areas and Primary Activities

• Completes audits of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement
• Creates and maintains assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPA’s.
• May assist in the induction process for new starters.
• Generally follows standard procedures and consults with manager/supervisor on exceptions.
• Compiles data for reports and presentations – May interpret data and draw conclusions.
• Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
• Keep abreast of cGMP requirements as described in applicable worldwide regulations.
• Additional activities may be assigned by the manager/supervisor

Skills Required

• Possess a degree in an Engineering or Science discipline.
• Alternatively they must possess significant industrial experience.
• should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.
• Effective communications (oral/written) and interpersonal skills are necessary