Join a global healthcare company dedicated to enhancing the lives of millions through innovative medicines and solutions.
About Grifols
We are a leader in plasma-derived medicines and transfusion medicine, operating in over 110 countries and regions since 1909. Our commitment to diversity fosters an inclusive environment that values equal employment opportunities.
Job Description
The Quality Systems Specialist will report to the Quality Systems Supervisor and be responsible for managing Documentation Compliance Manager (DCM) and archiving in relation to QMS systems. Key responsibilities include:
* Management of DCM system
* Providing reports on Quality Management System (QMS) documentation as required
* Managing Documentation Archive for QMS documentation
* Authoring/reviewing Standard Operating Procedures (SOPs) related to GWWO QMS
* Communicating with cross-functional departments
* Coordinating Internal audit system in GWWO
* Managing Change Control system in GWWO
* Managing CAPAs in GWWO
* Qualifying/supervising vendors and suppliers
* Providing GMP training for personnel
* Trending and reporting Quality metrics
* Managing Annual Product Reports
* Contribution to the continuous improvement of the Quality Management System
Requirements
To be successful in this role, you will need:
* Minimum 2 years' experience in Quality Systems/Document Control
* Extensive knowledge of compliance and EU/FDA GMP guidelines
* Degree in a science, pharmacy, or related field
* Previous experience in regulatory audits and Annex 1 requirements
* Experience working in a team environment and participating in Project teams
* Competence in Microsoft packages (Word, Excel, PowerPoint)
* Ability to work proactively and independently
* Excellent technical writing and analytical skills
* Good organizational and time management skills
* Flexibility and results-orientation
What We Offer
This is a fantastic opportunity to grow your career in a rapidly expanding organization. Grifols values its employees and provides a comprehensive benefits package, including:
* Competitive salary
* Group pension scheme
* Private Medical Insurance
* Ongoing career development opportunities
* Succession planning and internal promotions
* Wellness activities
If you are passionate about quality and have what it takes to succeed in this role, we encourage you to apply.