Qualified Person (36 hours)

The release or rejection of radiopharmaceuticals produced by BV Cyclotron VU

Work environment
BV Cyclotron VU is located on the Vrije Universiteit campus in Amsterdam and will soon be moving to the new award-winning (healthcare building of the year 2020) Amsterdam UMC Imaging Center, bringing together laboratories, researchers and practitioners in one building for the first time. This is unique for the Netherlands. The Imaging Center houses state-of-the-art imaging equipment such as MRIs, CT and PET scanners, optical equipment and four cyclotrons or particle accelerators.

Over a quarter of the speed of light: that is how fast the particles in the state-of-the-art cyclotrons in the basement of the Imaging Center move, eventually producing radioisotopes. In the modern GMP facilities, BV Cyclotron VU daily produces radiopharmaceuticals that are used throughout the Netherlands and abroad to detect various forms of cancer, neurological disorders or cardiovascular diseases, as well as for drug efficacy research. Annually, with a team of about 40 employees, we supply diagnostic radiopharmaceuticals to Dutch hospitals, accounting for about 80,000 patients per year.

 Job description

As a Qualified Person, you are ultimately responsible for the certification of batches of radiopharmaceuticals for human use. Hereby the main tasks and responsibilities are:

• End responsible for verifying that production and QC as defined in the Marketing Authorization or IMPD have been performed and meet specification;
• End responsible for certifying that batches have been produced and analyzed in accordance with Good Manufacuturing Practices;
• End responsible for releasing batches;
• Identifying and addressing non GMP compliance situations;
• Responsible for assessing pharmaceutical product complaints for impact on quality, efficacy and safety, and if necessary decide on a recall in collaboration with the MAH;
• You are responsible for setting up and implementing the Pharmaco Vigilance program;
• You authorize procedures related to the quality management system;
• You authorize product specific reports (e.g. PQR reports, Stability reports, Process validation reports);
• You perform early QP shifts and you are available outside working hours in case of any problems/calamities.

Profile
We are looking for a Qualified Person who brings the following knowledge and experience:

• You have a completed university education of at least 4 years in one of the following exact sciences: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology or otherwise as defined in Article 49 of EU Directive 2001/83/EC.
• You would like to work in a company with a social interest;
• You have at least 2 years of experience in a pharmaceutical company with a manufacturer’s license, ideally with radiopharmaceuticals;
• You have knowledge of analytical techniques and aseptic preparations;
• You have proactive collaboration with internal and external stakeholders;
• You can communicate clearly and concisely in word and writing in Dutch and English.

Employment conditions
Cyclotron initially offers a contract for the duration of one year which, in case of good performance, can be converted into a permanent contract. You will be appointed at BV Cyclotron VU and we follow the collective bargaining agreement and terms of employment of VUmc.

Interested?
Does this position suit you and are you interested in this vacancy? Then we would like to get to know you. Apply by sending your motivation letter and CV to Anita Gaspar at hrm@cyclotron.nl

Would you first like to know more about this position or about BV Cyclotron VU? Then you can call Touria El Hamdaoui, Manager Quality Assurance, phone nr. 020-4449123.

Acquisition in response to this vacancy is not appreciated.