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Qualified Person - Denmark  

Company managed [?] Still accepting applications

Posted on : 08 May 2017

Project Description

for Parallel Import (Medicine Division)
 Our fast growing Quality Assurance Department  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 our company 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. 
  • 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