Senior Specialist QA-IT (Operations)
msd
Dublin, IE
32d ago

Senior Specialist QA-IT (Operations) Job

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Enter your email to apply Requisition ID : QUA007492

MSD BIOTECH DUBLIN

Are you ready to Invent, Impact, Inspire?

Join MSD and shape the future of biotech in Ireland

INTRODUCTION

At MSD Ireland, we are committed to Inventing for Life’ in all that we do, pushing the boundaries of science to discover new medicines that treat the world’s most significant health challenges and benefit patients globally.

As one of the world’s leading healthcare companies, we are committed to making a difference. We are now looking for a Senior Specialist in QA Automation to play a pivotal role in the development of our new world-

class biotechnology facility in Dublin where they will have the opportunity to help shape the future of biotech in Ireland and play a significant role in the next chapter of our invention and discovery story.

THE OPPORTUNITY

Dublin, Ireland has been chosen for MSD’s first ever Large-Scale Mammalian-Based Drug Substance Facility. This facility will be a significant supplier of drug substance for one of MSD’s key treatments and will also be critical in the future supply of new biotechnology products to our global network.

Construction on this exciting new facility will commence immediately and this is a unique opportunity for the right person to shape, create, build and grow the Quality Assurance strategy of MSD Biotech, Dublin which will support the manufacture of MSD’s biologics-

based medicines, including in the area of immuno-oncology.

As one of the inaugural Quality hires in the core project leadership team, the QA IT Senior Specialist’s role will be essential in ensuring efficient and effective compliant design, construction, qualification, approval and operation of the new state-

of-the-art facility during the initial project phase. The successful candidate will take a lead on utilising the latest innovations in technology and automation to create a workplace of the future.

THE ROLE

The QA IT role will involve steering the entire development of the facility’s Quality Assurance IT strategy, ensuring the processes conform to MSD’s policies and comply with cGMPs, Health Agency regulations and all other applicable governing regulations, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world.

Close collaboration with high performance talent from MSD’s global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes will be key, and the successful candidate will inspire his / her team to build the future of MSD biologics through a Quality culture that delivers unconstrained supply, that is Right First Time to patients worldwide.

Providing training and guidance on the interpretation and implementation of MSD policies and regulatory requirements will also be key priorities for the Senior Specialist.

Throughout the development of the new facility, the successful candidate will focus on automation, commissioning, and / or quality system build.

Qualifications

With energy and enthusiasm, the QA IT Senior Specialist will :

a) be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.

b) be involved in all quality-related activities for computerized systems which are required by the MSD Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity.

c) will work closely with stakeholders and SMEs from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.

  • d) inspire and motivate his / her team to uphold a high performance culture that drives Quality Assurance excellence;
  • THE CANDIDATE

    This role requires a seasoned QA Senior Specialist with a minimum of 5 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.

    Must have at least 3 years of experience in delivering validated IT solutions or an application support role in a regulated environment.

    A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.

    Demonstrating quality interpersonal skills, he / she will communicate effectively with their team, and through decisive decision making, contribute to the organisation’s overall capability to thrive and grow.

    To ensure deliverables are met, the QA IT Senior Specialist will embrace accountability and responsibility, balance flexibility and endurance in the achievement of set targets, and confidently tend to stakeholder relationships of all-kinds.

    With a Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence.

    The candidate will also show ambition and drive to develop and advance their career within MSD.

    THE COMPANY

    MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago.

    We currently employ over 1,700 employees, across four sites in Ballydine, Co. Tipperary, Brinny, Co. Cork, Carlow and Dublin and, in addition, operate substantial Human Health and Animal Health businesses.

    To date, we have invested $2.5 billion in our Irish operations and currently our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world.

    With almost 70,000 employees operating in more than 140 countries, you will be joining one of the world’s largest pharmaceutical companies.

    So, if you are ready to :

    INVENT solutions to meet unmet healthcare needs

    IMPACT the future by driving MSD’s position as one of the world’s leading healthcare companies

    INSPIRE your team to reach their full potential and push the boundaries of science and technology

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