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.

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

#LI-FD1

Grange Castle International Business Park, Grange, Clondalkin, Co. Dublin, D22 K2R3 (https://www.google.com/maps/place//data=!4m2!3m1!1s0x486773bd46855f9f:0xbe0e9ad7159de122?sa=X&ved=2ahUKEwjlosT9q-KEAxUeQEEAHaEGCV4Q4kB6BAgREAA)

Learn more about Grifols

Req ID: 523685

Type: Regular Full-Time

Job Category: