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GDP Quality Technician

Location: 

Dublin, IE

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  546736

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.  

 

Position Summary:

 

Reporting to the GDP Quality Supervisor, the GDP Quality Technician is responsible for ensuring compliance with EU Good Distribution Practice (GDP) Guidelines 2013/C 343/01, HPRA Wholesale Distribution Authorisation (WDA) at GWWO. The GDP Quality Technician will also assist in ensuring compliance to the Manufacturers Authorisation in where it is impacted due to distribution activities and the receipt and storage of Plasma.

The GDP Quality Technician will assist in ensuring continuous improvement of the Quality Management System (QMS).

 

What You’ll Do:

  • Support the maintenance of the GWWO quality management system.
  • Support the management of authorised activities and the accuracy, and quality of the records.
  • Communicate with cross functional departments to ensure continued support of compliance system under the WDA.
  • Communication with the manufacturing sites of Grifols in relation to QMS activities where appropriate.
  • Support compliance with the general conditions of Wholesale Distribution / Manufacturing Authorisations, guidelines, and other legal requirements.
  • Assist in preparation and review of SOPs and other quality documentation in the GDP department and the Plasma area.
  • Support of customer complaints in relation to GDP.
  • Support completion of deviations related to distribution and plasma operations.
  • Ensure the GDP Quality Manager or the Technical Director is appraised on all quality related issues relating to GDP.
  • Provide support to the GMP area as required. 
  • Ensure Bona Fides are maintained, and periodic review is completed for Suppliers and Customers.
  • Participate and support in the internal audits program.
  • Support the Site Pest Control program.
  • Management of assigned projects using QMS tools.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
What You Will Bring:
 

Essential Skills & Knowledge:

  • Experience working in distribution / manufacturing and supply chain experience in the pharmaceutical or related industry, working under quality management systems in an environment of continuous improvement.
  • Experience in using Microsoft packages.
  • Degree in a science, pharmacy, or related discipline.

 

Desirable Skills & Knowledge:

  • Experience of working in a team environment and participating in Projects.
  • Experience in Documentum Management System.
 
Key Competencies:
  • Excellent people and time management skills.
  • Strong technical writing and analytical skills.
  • Excellent communication and teamwork.
  • Ability to work proactively on own initiative.
  • Experience reviewing temperature monitoring data and distribution records.
  • SAP experience, including familiarity with inspection plans, customer master data, and stock movements.
  • Experience with of EU/GDP Requirements.
  • Experience and understanding of a QMS.

 

Our Benefits Include:

  • A highly competitive salary package
  • Group pension scheme - Contribution rates are (3%/ 5%/ 7%) and company will match
  • Private medical insurance for the employee
  • Ongoing career development opportunities within a rapidly growing organisation
  • Strong focus on succession planning and internal promotion
  • Dedicated education and professional development allowance
  • Wellness and social initiatives, including activities such as padel and summer events

 

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you

#LI-AM1

Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3    

 

Learn more about Grifols

 

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