Site Name:
Ireland - Dublin
Posted Date:
Apr *******
We are looking for a medical device specialist to join our team on a 12-month fixed term contract basis.
The successful candidate will prepare and review batch verification dossiers for medical devices supplied globally.
You will work with manufacturing sites, external quality, supply chain and regulatory teams to ensure timely and compliant batch verification.
We value people who are curious, dependable, and clear communicators.
This role offers strong learning and growth opportunities and a chance to make a meaningful impact by helping ensure safe and effective products reach patients.
Join us to unite science, technology and talent to get ahead of disease together.
This role is offered on a hybrid basis.
You will work from the Dublin, Ireland site and from home as agreed with your manager.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included.
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
In this role you will
Prepare and review batch dossiers for medical device verification, including manufacturing, packaging and test records.
Ensure batches verified are maintained, and dossiers and samples archived in accordance with local SOPs and MDR ******** requirements.
Key performance indicators generation and reporting.
SOP/report preparation and approval.
Raise, investigate and close deviations, support change controls related to batch verification.
Support periodic product reviews, complaints and adverse event reporting, and trending activities.
Maintain and support compliance with quality systems such as ISO ***** and local regulatory requirements.
Communicate status and escalate quality issues to manufacturing sites, supply chain, external quality and regulatory stakeholders.
Participate in audits and self-inspections and support responses to inspection findings.
Basic Qualifications & Skills
Minimum education requirement of Leaving Certificate (Higher Level) or equivalent, including QQI Levels 3–5 or Junior Certificate.
A degree in a relevant scientific discipline is desirable.
Experience in quality review of batch records, deviations and test results within a regulated environment.
Working knowledge of medical device quality requirements, Good Manufacturing Practice or similar standards.
Experience with quality documentation, investigations, root cause analysis and corrective/preventive action processes.
Strong communication skills with experience working across multi-disciplinary teams.
Proficient with common office IT tools and comfortable learning quality management systems.
Preferred Qualifications & Skills
Familiarity with ISO ***** and medical device regulatory requirements (for example MDR).
Experience with electronic quality systems such as Veeva QMS, Veeva Vault or similar.
Previous experience supporting regulatory inspections or presenting data to regulators.
Knowledge of distribution and storage quality practices.
Experience in batch release processes for products manufactured outside the region.
Experienced in manufacturing site operations, batch record review, quality data review and operational quality requirements.
A detail-focused approach with evidence of continuous improvement or process optimisation work.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Closing Date for Applications – 24th April **** (COB)
GSK is an Equal Opportunity Employer.
This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us at ****** where you can also request a call.
This information is provided to assist you with your application.
It does not constitute a guarantee of employment or a statement of intent to employ.
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