Medical Device Specialist

Site Name: Ireland - Dublin Posted Date: Apr 30 2024 As a Medical Device Specialist , you will be preparing dossiers for the batch verification of medical devices. This will involve reviewing batch deviations, change controls and test results. 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 webpage Life at GSK | GSK Key Responsibilities include, but are not limited to:

• Liaise with External Quality, Sites, Manufacturers, and other groups for co-ordination of batch verification.
• Support the Associate Director, Medical Devices in compliant batch review and ensure timely escalation of any issues identified,
  • Review associated records and documentation, including deviations, changes and tests.
  • Raise and investigate deviations relating to medical devices processes including batch verification.

• Conduct activities to support Quality Systems (including ISO 13485) including:
  • Quality meetings
  • Deviation management
  • Customer Complaint and Adverse Event/Serious Adverse Event management and trending
  • Key performance indicators generation and reporting
  • SOP / Technical report preparation and approval
  • Conduct/participate in audits / self-inspections
  • Periodic Product Reviews
  • Processes effectiveness checks

• Ensure batches verified are maintained, and dossiers and samples archived in accordance with local SOPs and MDR 2017/745 requirements.
• Effectively communicate with Supply Chain Hubs, Local Operating Companies, manufacturing sites, External Supply managers and other stakeholders in the business.
• Present data on GSK’s behalf during regulatory inspections of the team.

Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals,

• Educated to GCSE/A Level standard (or equivalent). May hold a degree in a relevant science subject.
• Working knowledge of medical device, GMP and GDP regulations and experience in manufacturing site operations, batch record review, quality data review and operational quality requirements.
• Able to present on aspects of the medical device certification process where role holder has responsibility during regulatory inspections.
• Experienced in application of GPS thinking and tools and knowledge of performance measures
• Understanding of quality management principles and demonstrated experience of quality documentation review.
• Knowledge and experience of self-inspection processes and participation experience..

Preferred qualifications:

• Understanding of ISO 13485 and MDR 2017/745 compliance.
• Experience of using systems such as Veeva Quality Doc and Veeva QMS and Team Sites.

Closing Date for Applications – 14th May 2024 (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. At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. Find out more: Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. 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