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.
- Track and maintain a data base of distribution and Wholesale Dealers licences, Quality Agreements and identify potential gaps in accordance to GDP expectations.
- Support the Responsible Person (RP) activities in relation to the Wholesale Distribution.
- 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.
- 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.
- Maintain 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%
- A degree in a scientific area
- Minimum 1 year relevant experience in Quality in a distribution environment in the pharmaceutical industry
- Knowledge of GDP
- Able to interpret and rationalise data output
- Ability to perform audits, internally and externally
- Market rate basic salary
- Central location in Amsterdam easy reachable with public transport
- Growth opportunities getting sponsored to become a certified responsible person
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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