Quality Systems Specialist
Quality Systems Specialist
Reporting to the Quality Systems and Compliance Manager, 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, managing Change Control system, CAPA system, Supplier complaints, the process of vendor/service provider qualification and other activities related to QMS.
Other additional duties may be assigned by the Technical Director/ Quality Systems and Compliance Manager from time to time if required.
Contribution to the continuous improvement of the Quality Management System is required.
Extensive knowledge and understanding of regulatory requirements and guidelines.
Experience/certification in auditing will be considered an advantage.
Experience working in an aseptic area and understanding of Annex 1 requirements will be considered an advantage.
* 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)
* Communicate with cross functional departments
* Communication with the manufacturing sites in relation to QMS activities where appropriate
* Management and coordination of Internal audit system
* Management and coordination of Change Control system
* Management and coordination of CAPAs
* Management of the Suppler Qualification/Performance assessment process
* Management of Supplier complaints
* Providing GMP training for personnel working in aseptic and non-aseptic environment
* Trending and reporting of Quality metrics
* Managing of Annual Product Reports
* Contribution to the continuous improvement of the Quality Management System
* Management of GMP introductory and annual refresher training for all employees
* Any other training in relation to Compliance, as required
* Provide support to corporate and health authorities' site audits and response to audits' findings
* Provide active support to ensure audit readiness and compliance with regulations and Health Authorities' expectations
* Other duties as required by the Technical Director/Quality Systems and Compliance Manager
Skills and Qualifications
* Excellent communication skills
* Competence in Microsoft packages specifically Word, Excel and PowerPoint
* Ability to work proactively on own initiative
* Ability to work independently
* Excellent technical writing and analytical skills
* Good organizational and time Management skills
* Results orientated
* 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
* Degree in a science, pharmacy or related discipline.
* 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
For more information Contact Ann Marie Corcoran