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embecta

Quality Systems Coordinator

Posted 5 Days Ago
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Dun Laoghaire, Dublin
Entry level
Dun Laoghaire, Dublin
Entry level
This role involves managing compliance with GMPs, reviewing quality documentation, supporting product release, and assisting with regulatory audits.
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embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X.  

Why join us?  

A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life’s purpose through the work that they do every day. 

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. 

We are seeking a detail-oriented and collaborative Quality professional to join our team as a key contact for cross-functional departments, providing expert guidance on GMP compliance and quality standards. This role involves reviewing and maintaining quality documentation, supporting product release, preparing technical reports, and playing a vital role in regulatory and customer audits.

Responsibilities:

  • Be a primary contact for other departments providing quality guidance to assure compliance.
  • Manage compliance with relevant GMPs and promote quality improvements.
  • Review quality records including batch history records and other Quality documentation as required.
  • Maintain all batch history records and related documentation.
  • Work with cross-functional teams to support product release.
  • Prepare technical documentation.
  • Support the coordination and maintenance of the Documentation System.
  • Collate, review and report on process performance at department and site levels.
  • Be a key member of the site audit team, supporting all Regulatory and Customer audits.
  • Attend and contribute to departmental and other meetings.
  • Provide support for the Quality Management System as determined necessary by Quality Management.

Educational Requirements and Relevant Experience: 

  • Science/Engineering qualification
  • Experience working within an established Quality System

Knowledge, Skills and Abilities:

  • Excellent interpersonal and communication skills
  • The ability to work progressively as part of a team and on own initiative
  • Eager to learn and follow direction
  • Excellent attention to detail

Fixed Term Contract (Fixed Term)

embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Top Skills

Gmp Compliance
Quality Management System

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