Quality Systems Contractor
Industry : Healthcare
- Assume a lead role in the oversight and maintenance of the Quality Management Systems identifying areas for improvement & optimisation to support operational and release functions.
- Monitor and report Quality Systems & Standards implementation progress, notifying any predicted shortfall or discrepancies against timescale and budgets.
- Review and approve of site documentation including SOPs, Reports, Protocols to ensure compliance.
- Review and approval of non-conformance reports including deviations, laboratory investigations & environmental excursions to ensure compliance and timely closure.
- Responsible for site quality system governance through management review to ensure its continuing suitability and effectiveness.
- Responsible for running & co-ordination of site quality council meetings and presentation of trends, data and performance versus site and platform quality metrics.
- Through Key Quality Performance Indicator Dashboard, monitor site quality systems performance to ensure they consistently remain in place, in use and in control, comply with company Global Quality Policies and Standards and meet the most current regulatory requirements and best industry practices.
- Participate in Site regulatory inspections, internal audit program and vendor audits. Set up and implement associated remediation and continuous improvement programs on time in full and monitor CAPA effectiveness.
- Participate in or lead internal and external audits including 3rd party audits and supplier reviews.
- Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure quality objectives are understood and achieved.
- Ownership and oversight of site Change Control Process to ensure implementation of change control activities in accordance with site procedures.
- Implementation of the site risk management process and maintenance of Site Risk Register.
- Develop and where appropriate deliver training across the teams regarding the quality topics and metrics.
- SME and key point of contact on quality systems such as deviations, CAPA’s and change controls.
- Oversee site training programme.
- Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
- Partake in or lead periodic quality review meetings to ensure compliance and continuous improvement.
- Support the development of quality goals and targets as part of the organisation’s strategic plan.
- Write or assist in writing, reviewing and approval of SOPs and other GMP documents.
- Ensure GMP documentation is properly managed and archived.
- Serve as a quality culture role model and instill a strong quality and compliance culture across the site.
Location: Midlands, with a mix of on-site and remote working
Duration: 6 to 9 months – 3 days per week