EQMS & QSAP Supervisor
Dublin, IE
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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. |
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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 and Compliance Manager. The EQMS & QSAP Master Data Supervisor is responsible for management compliance to site master data.
Note: due to the nature of the business additional duties may be assigned from time to time.
KEY RESPONSIBILITIES:
- Management of EQMS on site
- Super user and master data compliance SME
- Provide Reports to site in relation to Quality Management System (QMS) as required.
- Provide regular KPI reports to leadership and departments as requested
- Authoring of Standard Operating Procedures (SOP’s)
- Authors and Leads department Change Controls as needed
- Management of deviations and CAPA related to EQMS & QSAP Master Data and support across the site
- Contributes to the Annual Product Reports
- Management of Quality SAP activities
- Communication with the manufacturing sites of Grifols in relation EQMS & QSAP Master Data
- Liaise with global team for updates and regulatory changes in the system
- Maintains audit readiness and supports audits
- Ensure new regulations and guidelines are correctly and promptly incorporated into GWWO practice
- Applies ICH Q9 Risk Management to EQMS & QSAP Master Data
- Trends, analyses, and reports on quality data
- Knowledge of master data and digital data integrity practices as set out in the EU Annexes
- Provide oversight in data integrity for validation of new and existing systems
- All listed tasks and responsibilities are deemed as essential functions to this position others may arise to meet the businesses needs
KEY COMPETENCIES
- (if applicable) Skills and abilities
- Excellent verbal, written and digital communication skills,
- Ability to handle multiple tasks and priorities with exceptional organisational time management skills
- Working knowledge and mastery in SAP, Veeva Vault, LSQM, PAS-X, Smartsheets, Systech, Cognex, Aizon.
- Competence in Microsoft packages specifically word, excel and PowerPoint
- Ability to work proactively on own initiative
- Excellent technical writing and analytical skills
- Experience of conducting systems and audit trail data audits
- Experience in leading cross-functional teams
PERSON SPECIFICATION
Qualifications
- Minimum of 5 years’ experience in Quality Systems/Quality Assurance environment
- Excellent understanding of GMP regulations and guidelines
- Previous experience in managing/supervising
- Previous experience with health authority audits
- BSc or MSc in a science, pharmacy or related discipline
- Experience of leading audits
- Certification in auditing will be considered an advantage.
- Experience in working in aseptic area and understanding of Annex 1 and other related EU GMP Annexe requirements will be considered an advantage.
Our Benefits Include:
- Highly competitive salary
- Group pension scheme - Contribution rates up to 7%.
- 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
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Location:Grange Castle International Business Park, Grange, Clondalkin, Co. Dublin, D22 K2R3