Qualified Person

Qualified Person

for Parallel Import (Medicine Division)



Our fast growing Quality Assurance Department based in Budapest is looking for a QP who will ensure that all the activities during the secondary packaging have been performed according to the cGMP rules.

Responsibilities:
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).
Ensure that every batch of medicines manufactured on site are produced, examined and stored according to the relevant legislation and marketing authorizations.
Operating and maintaining our quality management system.
Write, revise and approve SOPs.
Quality process improvement.
Monitoring, enforcement and compliance of the pharmaceutical standards (GMP, GDP).
Supervise deviation, complaint and change control management.
Interaction with public authorities, representation of the company, data service for OGYÉI.
Corrective and preventive actions (CAPA) management.
Participation in internal and external audits (supplier, outsourced activities).
Participation in project implementations and IT validation projects.
Review and approve qualification documents.
Control that all the employees of Abacus Medicine Hungary receive the necessary training regarding to GMP.

Education:
Pharmacist

Requirements:
5 years+ 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 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 on weekends.
The positions requires average user level of computer skills.

IF:
– 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

please send your English and Hungarian cv to allas2@abacusmedicine.hu.