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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.
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
The Quality Compliance Specialist is responsible for the execution of a variety of compliance requirements within the Quality Management System (QMS) of the site. This role is key in maintaining and updating compliance activities throughout the site. While ensuring management’s awareness of the systems performance. The execution of all applicable requirements related to QMS, Corporate requirements, Regulatory compliance, and applicable Grifols Policies or Procedures.
What You'll Do
Potential Responsibilities at management discretion:
- Provide Reports to site in relation to Quality Management System (QMS) as required.
- Provide regular reports on site’s metrics to appropriate management
Management and ownership of:
- Quality system integration
- Data Integrity system
- Applicable training requirements (i.e. GMP introductory and refresher training)
- Quality Risk Management
- Supplier management system
- Support the completion and execution of Site Quality Council and Annual Product Reports
- Communicate with cross functional departments sites’ compliance and quality systems issues
- Supporting or Conducting audits of suppliers/outsourced providers, where applicable
- Supporting the coordination of self-inspection system in GWWO, where applicable
- Provide support ensuring external audit readiness and during external audits and corporate internal audits
- Ensures the corrections of findings, risks and recommendations are promptly and thoroughly incorporated into the quality systems
- Identifies and shares "Best Practices"
- Participate in investigations of quality system issues and drives CAPA implementation to ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated
- Trends, analyses, and reports on quality data to improve product and process Quality; develop recommendations based on data analyses
Responsibilities include managing and coordinating (not Exhaustive)
- Supplier qualification process, supplier complaints, and supplier agreements
- Quality Risk management
- Data Integrity management
- Other activities related to QMS.
Other additional duties may be assigned by the Quality Systems & Compliance Management, if required.
What You'll Bring
Competence in Microsoft packages specifically word, excel and PowerPoint
Ability to work proactively on own initiative
Excellent technical writing and analytical skills
Flexibility
Results orientated
Process improvement and procedure writing expertise
Experience of conducting audits
Detail oriented, well organized and able to work independently and in teams
Good communication skills both verbal and written
Flexible, able to adapt quickly to change in a fast-paced environment
Solid problem-solving skills
Previous experience in auditing
Previous experience in health authorities’ audits
Qualifications:
Bachelor’s degree (B.A./B.S.) or equivalent
Two to four years’ experience in the pharmaceutical and/or biotechnology-based industry (as deemed necessary by hiring manager).
Experience with assisting or managing QA audits and inspections.
Good working knowledge of pertinent regulations and site SOPs.
Demonstrates strong communication and facilitation skills.
Certification in auditing will be considered an advantage.
MSc in a science, pharmacy or related discipline an advantage
Our Benefits Include
Highly competitive salary
Annual performance-based bonus
Share options scheme
Group pension scheme with company matching contributions
Private Medical Insurance
Ongoing opportunities for career development
Succession planning and internal promotion opportunities
Education assistance
Wellness and social activities
Collaborative and inclusive working environment
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.
Location: Grange Castle International Business Park, Clondalkin, Dublin, Ireland.
Location: Grange Castle International Business Park, Clondalkin, Dublin, Ireland
Learn more about Grifols
