Quality Compliance Specialist - 12 Month FTC

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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