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Quality Systems Specialist

Location: 

Dublin, IE

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  95667

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Quality Systems Specialist

 

Responsibilities include managing and coordinating the internal audit system, managing change control system, the process of vendor/service provider qualification and other activities related to QMS.

Contribution to the continuous improvement of the Quality Management System is required.

 

The Role

  • Management of Documentation Compliance Manager (DCM) system and archiving in relation to QMS systems
  • Provide reports to site in relation to Quality Management System (QMS) Documentation System as required.
  • Authoring of Standard Operating Procedures (SOP’s) in relation to the Documentation System
  • Communicate with cross functional departments
  • Communication with the manufacturing sites in relation to QMS activities where appropriate
  • Management and coordination of CAPAs
  • Provide administration support in relation to Annual Product Reports
  • Management of GMP introductory and annual refresher training for all GWWO employees
  • Provide support to corporate and health authorities’ site audits and response to audits’ findings
     

Requirements

  • Excellent communication skillsCompetence in Microsoft packages specifically Word, Excel and PowerPoint
  • Ability to work proactively on own initiative
  • Excellent technical writing and analytical skills
  • Good organizational and time Management skills
  • Flexibility
  • Results orientated
  • Minimum of 2 years’ experience in an Document Control role preferably in a Quality Control/Assurance setting and with experience in using Microsoft packages
  • Experience in managing/coordinating Change Controls, CAPAs
  • Degree in a science, pharmacy or related discipline.
  • Extensive knowledge and understanding of regulatory requirements and guidelines.
  • Experience in the pharmaceutical or related industry working under quality management systems

 

Desired Requirements

Experience of working in a team environment and participating in Project teams.

Experience in Documentum

Experience/certification in auditing

 

 

 

 

 

Location: EMEA : Ireland : Dublin:Grange Castle (Dublin) 

 

Learn more about Grifols