Job Purpose

• Designing and providing continuous improvement of Quality Management Systems.
• Monitoring and production of metrics of GMP compliance with current Quality Management Systems.
• Supporting all aspects of supplier qualification and ongoing risk management.
• Providing primary Quality support for new products, projects and suppliers/service providers as required.
• Conducting internal audits and following up to promote continuous improvement.
• Supporting Annual Product Quality Reviews as required.
• Supporting the hosting of client and regulatory audits and inspections.
• Supporting and co-ordination of responses to client and regulatory audits and inspections.
• Acting as a point of contact for client quality assurance queries.

Responsibilities

• Supporting the quality of GMP manufacturing practices (i.e. aseptic practices) and or analytics during manufacturing/ testing of drug/vector substance/product to ensure adequate and timely release of GMP compliant product in accordance with CTA, IND and site-specific authorisations.
• Providing direct quality team support during customer and regulatory audits.
• Creation and maintenance of a state of readiness in order to satisfy regulatory and client expectations during audits and inspections.
• Working in a team in order to prepare and ensure the site systems are compliant and meet GxP and Quality expectations.
• In depth knowledge of the pharmaceutical industry in terms of regulations and compliance.
• Awareness and understanding of Quality Systems in order to support them effectively.
• Communication of compliance updates.
• Knowledge of the different aspects of the OXB business in order to assist in investigations.
• Actively support continuous improvement of Quality Management Systems, representing Quality in new projects to ensure quality is built in as early as possible.
• Supporting Quality based projects working as part of a multidisciplinary team as required.
• Promoting continuous improvement of the Quality Management System ensuring that the manufacturing and or analytics sites follow all SOPs which ensure that health, safety, environmental, quality standards are met.
• Ensuring and coordinating training in all aspects of Quality Management Systems and Quality related GMP, including procedural updates.
• Reporting on-going progress with QA activities and Deviations to Head of Quality.
• Attending meetings and follow up communications across the Quality Systems team and other departments.

Key skills and requirements

• Familiarity working within pharmaceutical Quality Assurance.
• Working knowledge of GMP & Quality related pharmaceutical regulations & standards.
• A level, National Certificate or equivalent in a Science discipline.
• Higher National Certificate, Degree or equivalent in science discipline is desirable.
• Computer literate (Word, Excel, MS Office).
• Solid working knowledge of Validation and Quality Management systems.

Requirements

• Experience of conducting quality based audits, investigations and root cause analysis.
• Understanding and experience of Change Control.
• Experience of regulatory and or customer /client audits and inspections.
• Understanding & experience of GMP and pharmaceutical industry QA requirements.
• Experience in document control or records management systems in a regulated environment.
• Good interpersonal and communication skills.
• Excellent attention to detail.
• Good team player, and must also be able to work alone.
• Good organisational and time management skills.
• Able to prioritise workload, decisive thinker and able to work within agreed timescales.
• Experience of use of an electronic Document Management system to GMP standards.