Our client is an ambitious player within the biotechnology industry and has been revolutionary in their approach of combatting life interrupting illnesses since 1980. Their sole purpose is to push the boundaries of modern science, to transform medicine and doing so with a singular focus on improving treatment results. They are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of!
For our client, we are looking for a dedicated International Distribution and Quality Officer to join the team in Breda.
* The applicable local regulations in relation to Distribution of medicinal products
* The European Pharmaceutical Directive related to Distribution of Medicinal Products
* Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP)
* The role of the professional bodies and organizations that regulate those supplying medicinal products to the public
* The role of the European Medicines Agency (EMA) and Country Health Authorities
* The Falsified Medicines Directive, as well as the EU Medical Device and In Vitro Device Regulation
* The Principles and Guidelines of GMP and how the principles of GDP maintain product quality throughout the distribution chain
You will support activities to maintain quality systems and execute tasks in compliance with the client's Quality Management System, GMP & GDP requirements and any local applicable regulations.
* documentation is accordingly processed
* records are accurate and up to date
* records are kept according to applicable requirements
Product Complaints and suspected falsified medicinal products
* Manage/oversee Product Complaint returns process
* Perform intake of incoming Product Complaints and additional follow ups with external parties, with different level of complexity depending on the case
* Follow up with complainants, Quality Complaints Team and third parties when appropriate
* Notify complainants of complaint closure
* Activities also include identification of Adverse Events, Medical Information enquiries and brand protection issues as well as potential counterfeit
* Ensure that internal and external customers are taken care of according to the client's policies and procedures
* Problem solving, under minimum supervision
* Autonomy and working under minimum supervision, seeking assistance as needed
* Contributing to teamwork by ensuring the quality of the tasks/services provided by self
* Ability to utilize appropriate tools and techniques to solve problems
* Fluency in English, and any additional language as required per the role
* Information and Communication Technologies
* MBO or equivalent in Life Sciences or in Supply Chain & Logistics Management
* At least 1 year of relevant professional experience
* Knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice
* Strong word processing, database and spreadsheet application skills
What we offer
* Initial contract via Kelly Services for 12 months
* Max salary of 3900 EUR per month, depending on experience
* Start date: August 2022
* A great opportunity to join an internationally recognized and inspirational organization in Life Sciences where your contribution will be highly valued and where you will get the chance to be part of challenging projects that change people's lives.
Contact us today!
T: 06- 12963210
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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.