Quality Assurance Officer
To support Distribution Quality in ensuring Good Distribution Practices (GDP) are followed and can be shown to have been followed. Work with Responsible Persons (RP) across the distribution network to provide support and guidance on quality and regulatory issues.
Maintain, support and improve the Quality Management System employed across the Norgine distribution network and to promote continuous improvements, whilst maintaining compliance with regulations and standards for medicinal product and medical devices.
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
Provide an oversight of Norgine distribution and Wholesale Dealers licences, identifying gaps proposing remediation work to be compliant with GDP expectations set in Eudralex Vol 4 and EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use.
• Build and agree internal self-inspection program
• Conduct and report on gaps identified in self-inspections
• Build and assist in building solutions and CAPA
• Monitor CAPA effectiveness
Support the Norgine BV Responsible Person (RP) activities in relation to the Norgine BV (NBV) Wholesale Distribution licence, in accordance with Eudralex Vol 4 and EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use.
• Accept tasks assigned / delegated by the RP
• Ensure systems for supplier and customer bona fides are in place, current and readily available to affiliate companies
Ensure Norgine Quality Standards are understood and applied at Affiliate and Distribution partner level. Maintain support for and propose improvements to the Quality Management System.
• Perform review of new and emerging legislation to assess compliance
• Monitor compliance indicators for emerging issues and trends
• Draft proposals for maintaining compliance
Support the global lead to ensure that Norgine affiliate companies, distribution Partners and manufacturing sites have a clear understanding of Norgine expectations in GDP.
- Perform periodic review GDP procedures, update as needed
- Train out new procedures as needed
- Monitor performance against procedures
Collect and report data to support the metrics that deliver understanding of the levels of compliance through the distribution network. Identifying noncompliance and associated risks and risk reduction strategies with clearly communicated action plans.
- Continuously review data and relevance to ongoing compliance
- Recommend changes to metrics to better support understanding of GDP compliance
- Collect compliance indicating data, review and identify relevant signals
- Report potential signals to management
Support the RP Forum, sharing knowledge, compliance issues, training and mentoring to the group.
- Identify training opportunities for meetings and deliver to maintain Continuous professional development of RP's
- Provide point of contact and knowledge management
Support the Global Distribution Quality Council, providing administration, record keeping and organisation of presentations.
- Set meeting schedules, agendas and topics
- Ensure tracking and completion of actions identified
Act as lead in quality event management and investigations for significant quality events. Review, evaluate, and contribute to investigation into OOS or major deviations that are identified and follow-up on corrective actions associated.
- Raise deviations and ensure close out or escalation
- Appoint and or conduct investigations, ensuring root cause is determined and CAPA identified
- Close out investigations by providing Quality Assurance concurrence
Provide support to the Global Distribution team for ongoing operations and projects deployment in a compliant effective manner.
- Act as the Quality lead when assigned projects
- Complete tasks in a timely manner or escalate issues to line management
Identify and report quality risk and propose risk mitigation/ remediation plans with partners. Ensure the risk is reported and managed in appropriate manner to minimise impact on patient supply or to the Business.
- Maintain the risk register for Distribution
- Conduct risk assessments
- Take actions to reduce risks to an acceptable level
- Identify and report risks that are beyond local resources to remediate
- A degree or equivalent in a science or engineering subject is preferred
- A minimum of 5 years relevant experience in a Quality environment in the pharmaceutical industry with a sound Knowledge of GMP and GDP
- Line management experience.
- Strong communication and supervisory skills are essential.
- The ability to introduce, co-ordinate, complete and report on projects.
- A high level or self-motivation is necessary.
- Attention to detail
- Able to establish data needs, interpret and rationalise data output
- Influencing skills
- Ability to perform audits, internally and externally.