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Qualified Person - Denmark
Abacus Medicine (company)
Posted on : 07 July 2017
for Parallel Import (Medicine Division)
- Our company is a global supplier of prescriptive, original European pharmaceuticals. By utilizing parallel distribution, the company provides the same exact medicine at a significantly-reduced cost.Our company fills an important role in the health care sector by providing access to affordable medicine for both business and consumer.
- Established in 2004, with headquarters in Copenhagen, our company has been among the fastest growing companies in Denmark and has received Børsen Gazelle 6 times since 2010. This prize is given in recognition of being among the fastest growing companies in Denmark.
- As of 2017, our company has more than 1900 marketing licenses for pharmaceutical products distributed throughout pharmacies and hospitals in several European countries (e.g. Germany, Sweden, Denmark, The Netherlands, UK, Austria).
- The company engages in a large supplier network throughout Europe holding partnerships for many years and issuing the highest standard of service and integrity in every operational respect. Our customers are distributors of pharmaceutical products across Europe.
- Together, we contribute to an efficient pharmaceutical supply chain that lowers health costs for both the public and private sectors.
- In 2012 our company decided to spread its wings to the Center of Europe and company was established in Budapest. Starting small, the company has experienced an extensive growth in the processed goods with an increasing level of responsibility and a fast growing workforce.
- Currently our company is employing 230 dedicated and highly educated colleagues who are responsible for the whole repackaging, dispatching and quality processes.
- Several departments are working together in Hungary in close contact with the colleagues in Denmark and The Netherlands to prepare the valuable goods for the customers in the individual end markets.
- Now, our fast growing Quality Assurance Department based in Budapest is looking for a QP who will place the medicinal product on the market after secondary packaging.
- Adhere to and ensure compliance with company policies and procedures related to secondary packaging.
- Ensure that products meet the required standards various elements of current Good Manufacturing Practices (GMP).
- Finish products (solid dosage forms, injections, infusions, medical devices, etc.) batch record review and batch release.
- Supervise deviation, complaint and change control management.
- Interact with regulatory agencies (EMA, NCAs) regarding product deficiencies.
- Corrective and preventive actions (CAPA) management: Leading and participating in incident, deviation and out of specification (OOS) investigations. Monitoring efficiency of CAPAs.
- Review Product Quality Reviews (PQRs) and preparation of Abbreviated PQRs for partners.
- Review process validation plans and reports before approval.
- Participate in internal and external audits (GDP, outsourced activities), approve suppliers.
- Maintain the total quality system, participate in management and QP meetings.
- Write, revise and approve SOPs, Quality process improvement.
- Participate in project implementations and IT validation projects.
- Review and approve qualification documents.
- Supervision and coordination of local third party manufacturers and distributors.
- Supplier evaluation and approval.
- QP has to participate trainings regarding the production processes, technical advances and changes to GMP.
- QP has to control that all the employees of our company receive the necessary training regarding to GMP.
- 1 year+ relevant pharmaceutical industry experience in a GMP environment.
- QP will work in an international environment. As QP position is located in Budapest and he/she has to communicate spoken and written on a daily basis with colleagues in The Netherlands and Denmark, proficiency in English and in Hungarian is a must.
- For a smooth cooperation QP needs to have excellent developed communication skills to be able to cooperate with all the level of the organization in Hungary, Netherlands and Denmark.
- Depending on the workload, QP has to be flexible, occasionally willing to work in the weekends.
- The positions requires average user level of computer skills.
- your interest and background meets with our expectations
- you have strong communication skills
- you are a self-made and pro-active person
- you have strong quality mindset
- you are able to do multi-tasking
- you would like to be a member of a young and dynamic organization