Quality Systems Officer (contract) Oxfordshire
|Job Title:||Quality Systems Officer (contract) Oxfordshire|
|Contact Name:||Nathan Wilson|
|Job Published:||August 25, 2017 09:04|
- 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.
- 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.
- 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.
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