Quality Assurance Specialist Responsible Person Global Big Pharma Hungary

Budakeszi - Hungary

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Due to successful expansion our USA-based Global Big Pharma partner is looking for an additional team member to fill the role of Quality Assurance Specialist / Responsible Person in Hungary. This is a great opportunity to deepen your professional knowledge on pharmaceutical product release for the local and other EU markets.

Your tasks:

Assist with the integration and support of quality regulations: drug biologics device and/or combination products
Coordinate the Quality Management Review process at the affiliate
Represent affiliate QA in regional global and cross functional teams projects and programs as assigned by management
Coordinate the Quality Management Review process at the affiliate
Ensure that a QMS is implemented and maintained (all GDP related activities are clearly defined and systematically reviewed; responsibilities processes and risk management principles in relation to distribution activities are clearly specified; the quality system is fully documented and its effectiveness is monitored)
Ensure inspection of incoming goods and release to local market
Releasing products for local and other EU markets
As a responsible person the post-holder has the right to make decisions in terms of responsibilities laid down in Decree No. 53/2004. (VI.2.) of the Ministry of Health Social and Family Affairs on the wholesale and parallel import of medicinal products

You qualifications:

University Degree in Pharmacy
At least 1 year of practical experience in quality assurance of pharmaceuticals and pharmaceutical ingredients at one or more companies authorized for pharmaceutical wholesale
Comprehensive knowledge of national and EU GDP legislation
Proficiency in English
Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively

Should you be interested in this position please let us know by submitting your CV via the advertisement - our collegues will soon contact you with the details.

Required Experience:

Assist with the integration and support of quality regulations: drug biologics device and/or combination products
Coordinate the Quality Management Review process at the affiliate
Represent affiliate QA in regional global and cross functional teams projects and programs as assigned by management
Coordinate the Quality Management Review process at the affiliate
Ensure that a QMS is implemented and maintained (all GDP related activities are clearly defined and systematically reviewed; responsibilities processes and risk management principles in relation to distribution activities are clearly specified; the quality system is fully documented and its effectiveness is monitored)
Ensure inspection of incoming goods and release to local market
Releasing products for local and other EU markets
As a responsible person the post-holder has the right to make decisions in terms of responsibilities laid down in Decree No. 53/2004. (VI.2.) of the Ministry of Health Social and Family Affairs on the wholesale and parallel import of medicinal products

You qualifications:

University Degree in Pharmacy
At least 1 year of practical experience in quality assurance of pharmaceuticals and pharmaceutical ingredients at one or more companies authorized for pharmaceutical wholesale
Comprehensive knowledge of national and EU GDP legislation
Proficiency in English
Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively

Should you be interested in this position please let us know by submitting your CV via the advertisement - our collegues will soon contact you with the details.

Required Experience: