QA Officer Distribution - Pharma - get RP Qualification
My client, a European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century is looking for a QA officer to support their Distribution Quality. This is a challenging opportunity where you need to think outside of the box and where you can grow into a Responsible Person, opening a lot of future doors in your career.
- Support product quality by ensuring that transport conditions are monitored according to agreed schedules and that data is collated and reviewed and made available to responsible management.
- Track and maintain a data base of distribution and Wholesale Dealers licences, Quality Agreements and identify potential gaps against GDP expectations set in EudraLex Vol 4 and in particular EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use.
- Populate the data base to support WDA's is routinely updated and identify gaps or non-compliances in the data base and remediate.
- Support the Responsible Person (RP) activities in relation to the Wholesale Distribution licence, in accordance with EudraLex Vol 4 and in particular transportation arrangement and ensure systems for supplier and customer bona fides are in place, current and readily available to affiliate companies.
- Support the global lead to ensure that transportation conditions are mapped and monitored against agreed schedules. Taking a lead in proposing schedules and managing flow of devices and data.
- Ensure Quality Standards are understood and made available to Affiliate and Distribution partner level. Maintain support for and propose improvements to the Quality Management System.
- 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.
- Support the RP Forum, providing administration, record keeping and organisation of presentations sharing knowledge, compliance issues, training and mentoring to the group.
- Act as lead in quality event management and investigations for major and minor quality events. Review, evaluate, and contribute to investigation into OOS or major deviations that are identified and follow-up on corrective actions associated.
- Provide support to the Global Distribution team for ongoing operations and projects deployment in a compliant effective manner.
- 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
- Maintains excellent working relationships with all manufacturing sites, distribution organisation and Affiliate offices, liaise with distribution service providers and works closely with Affiliate RP's at local offices and Distribution service providers, this will require significant travel possibly up to 30%
What we are looking for in a candidate:
- A degree or equivalent in a scientific is preferred with 3 years relevant experience in a Quality environment in the pharmaceutical industry
- Knowledge of GDP, knowledge of GMP is a plus
- Strong communication and supervisory skills
- The ability to introduce, co-ordinate, complete and report on projects.
- A high level or self-motivation is necessary.
- Attention to detail
- Able to interpret and rationalise data output
- Ability to perform audits, internally and externally.
If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!
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