Medical Device Specialist – Batch Release

GlaxoSmithKline View all jobs

  • Dublin
  • Contract
  • Full-time
  • 6 days ago
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.Discover more about our company wide benefits and life at GSK on our webpageIn 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 2017/745 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 13485 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.
Why you?Basic Qualifications & Skills:We are looking for professionals with these required skills to achieve our goals:
  • 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:Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
  • Familiarity with ISO 13485 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 manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.Closing Date for Applications – 24th April 2026 (COB)Please take a copy of the Job Description, as this will not be available post closure of the advert.When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.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.We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.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.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the where you will find answers to multiple questions we receiveImportant notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at

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