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.
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.
* Managing CAPA system.
* Managing Supplier complaints.
* Managing the process of vendor/service provider qualification.
* Contribution to the continuous improvement of the Quality Management System.
* Other additional duties as assigned by the Technical Director/Quality Systems and Compliance Manager/Quality Systems Supervisor.
What your responsibilities will be:
* 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 (SOPs) in relation to GWWO QMS.
* Communicate with cross-functional departments.
* Communication with the manufacturing sites of Grifols in relation to QMS activities where appropriate.
* 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 Supplier Qualification/Performance assessment process.
* Management of Supplier complaints.
* Providing GMP trainings for personnel working in aseptic and non-aseptic environments.
* Trending and reporting of GWWO Quality metrics.
* Managing Annual Product Reports.
* Management of GMP introductory and annual refresher training for all GWWO 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 GWWO’s audit readiness and compliance with regulations and Health Authorities’ expectations.
* Other duties as required by the Technical Director/Quality Systems and Compliance Manager.
What you will bring:
* 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.
* 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.
* Flexibility.
* Results-oriented.
What we offer:
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Our Benefits Include:
* Highly competitive salary.
* Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match.
* 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 e.g., Golf, Padel, Summer Event.
If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.
We look forward to receiving your application.
Req ID: 524642
Type: Regular Full-Time
Job Category: Quality
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