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 Quality Systems Supervisor the Quality Systems Specialist is responsible for management of Documentation Compliance Manager (DCM) and archiving in relation to QMS systems.
Responsibilities include managing and coordinating the Internal audit system in GWWO, managing Change Control system, CAPA system, Supplier complaints, the process of vendor/service provider qualification and other activities related to QMS.


This is a 12 Month Fixed Term Maternity Contract


KEY RESPONSIBILITIES

• Management of Documentation Compliance Manager (DCM) system
• Provide Reports to site in relation to Quality Management System (QMS) Documentation System as required.
• Management of Documentation Archive for QMS documentation.
• Authoring/reviewing of Standard Operating Procedures (SOP’s) in relation to GWWO QMS
• Communicate with cross functional departments
• Management and coordination of Internal audit system in GWWO
• Management and coordination of Change Control system in GWWO
• Management and coordination of CAPAs in GWWO
• Management of the Suppler Qualification/Performance assessment process
• Management of Supplier complaints
• Trending and reporting of GWWO Quality metrics
• Managing of Annual Product Reports
• Contribution to the continuous improvement of the Quality Management System

PERSON SPECIFICATION
Essential/Desirable/Knowledge & Skills

• Minimum of 2 years’ experience in Quality Systems/Document Control role.
• Extensive knowledge and understanding of compliance, EU and FDA GMP guidelines
• Previous experience in managing/coordinating Change Controls, CAPAs, deviations, supplier qualification, supplier complaints
• Previous experience and contribution in site’s regulatory audits
• Experience/certification in auditing
• Experience in working in aseptic area and understanding of Annex 1 requirements
• Experience of working in a team environment and participating in Project teams.
• Qualifications
• Degree in a science, pharmacy or related discipline.

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are 5% employer and 5% employee
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Padel, 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

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


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