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QP-Eligible QA Specialist
Curium Pharma —Blackrock, County Dublin
- Bachelor's degree
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QP-Eligible QA Specialist
Curium Pharma —Blackrock, County Dublin
Take ownership, maintain and continuously improve the site Quality Management System (QMS), ensuring alignment with current regulations, guidelines and industry…
QA Engineer
Grouper —Dublin, County Dublin
Collaborative Sprint Planning: Collaborate with Product Owners and Developers to ensure sprint stories have clear acceptance criteria and provide guidance on…
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QP-Eligible QA Specialist

Curium Pharma -
Blackrock, County Dublin

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Job details

Temporary

Qualifications

Bachelor's degree
Quality systems
Communication skills
Time management

Full job description

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

Ensure Curium's compliance with the requirements of Good Manufacturing Practice
Take ownership, maintain and continuously improve the site Quality Management System (QMS), ensuring alignment with current regulations, guidelines and industry standards along with the site QPs

Note: The vacancy is a maternity cover (fixed-term contract).

Essential Functions

Ensure ongoing compliance with EU GMP Annex 1, Annex 3, Annex 11, Annex 16, HPRA, EMA regulations and Curium requirements.
Take ownership and maintain various aspects of the Quality Management System for PET radiopharmaceutical production.
Review, approve and manage deviations, CAPAs, Risk Assessments, root cause investigations, Change Controls, OOS/OOT, Complaints, recalls, withdrawals, Quality Agreements and Supplier Agreements.
Provide quality oversight for new product and technology launches and validation activities.
Initiate and champion continuous process improvements.
Support HPRA inspections, second-party and first-party audits.
Develop and deliver SOPs, Training programs and assess training effectiveness.
Track, trend and report Quality metrics.

Requirements

Minimum Bachelor’s degree in Pharmacy, Life Sciences, or a related discipline.
Educational qualifications meeting EU QP eligibility requirements as defined in Directives 2001/83/EC and applicable national legislation.
3+ years of Quality experience in a pharmaceutical manufacturing GMP environment.
Strong working knowledge of EU GMP Annex 1, Annex 3, Annex 16 and HPRA expectations.
Experience managing quality systems, audits, deviations, CAPAs, and change control.
Proven ability to work cross‑functionally and manage multiple priorities.
Batch release/disposition experience preferred.
Good communication and time management skills.

This position is fully site-based and requires on-site presence five days per week.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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