For our client - an innovative pharmaceutical company in Amsterdam, NL - we are looking for a QP to join a dynamic and dedicated team!
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.
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 English. Dutch is preferred.
- Location: Amsterdam, NL
- Start date: ASAP
- Permanent contract
- Full time: 36 hours a week
- 1 day working form home
Send your CV to Khanyi Mabena at firstname.lastname@example.org or contact her on +31 2020 44502.