Quality Assurance Specialist Shift IPT

The Quality Assurance Specialist (Shift IPT) role, reporting to the Quality Manager, is of paramount importance in coordinating shift priorities, providing guidance to QA IPT team members, and maintaining Quality oversight and support for the IPT. As a key member of the team, you will be responsible for implementing and supporting various Quality Assurance strategies, systems, and processes.

Your primary responsibility will be to uphold cGMP standards for the assigned areas, ensuring compliance with policies, Health Agency regulations, and other relevant governing regulations. Furthermore, you will play a vital role in fostering a strong Quality culture throughout the site.

Collaborating with a talented cross-functional team comprised of individuals from our company and the biotechnology industry, you will contribute to shaping the future by cultivating a Quality culture that enables us to deliver high-quality products to our patients with unmatched efficiency.

We are committed to your growth and development. You will receive active support and encouragement to enhance your knowledge and skills, with opportunities to expand your expertise in areas that align with your career aspirations and contribute to continuous improvement in your current role. Additionally, you will provide quality support to the site, including training and guidance on interpreting and implementing company Guidelines/Policies and regulatory requirements as needed.

Within our Quality Assurance group, we have stringent standards to ensure that all materials in our products are manufactured, processed, tested, packaged, stored, and distributed in strict accordance with our exceptional quality standards and meet all regulatory requirements.

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

Work a 4-shift pattern role involving technical knowledge of sterile manufacturing processes.

Perform timely reviews of batch documentation, investigations, and reports, highlighting and assisting in the resolution of concerns commensurate with the risk.

Respond quickly to unplanned events and technical issues (providing guidance to QA IPT team members for escalated issues)

Acts as Quality point of contact for the Quality Manager as required

Mentor of QAIPT shift Team members (providing guidance and technical support as required)

Lead continuous improvement initiatives to continually drive efficiencies and remove waste to help site deliver compliant products,

Provide support with audit/inspection requirements to ensure department compliance/readiness.

Operate quality systems in a dynamic manufacturing environment (e.g., SAP, Trackwise, MES).

Have a full understanding of relevant quality and compliance regulations, including cGMP, US, and EU requirements.

Conduct, report, and display Quality right first time and audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance.

Support the spot check/walk-through process of the production lines.

Be involved in customer complaint investigation if required.

Support the annual product quality reviews if required.

Provide Quality support to IPT production teams to ensure cGMP standards are maintained.

Preferably have an understanding of sterile manufacturing operations.

Have the ability to learn and utilize computerized systems for daily tasks.

Prioritize, manage multiple tasks, and meet deadlines.

Perform timely reviews on batch documentation (EBRs), line clearances, and assist in the resolution of concerns commensurate with the risk.

Liaise with other Department representatives to promote improvements in GMP and Quality standards.

Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities.

Comply with current Manufacturing Division, Quality, and EHS Management System requirements, as relevant to commercial operations.

Foster a culture of continuous improvement by deploying Our Company MPS tools and support implementation of Model Area within operations from the start.

What skills you will need:

In order to excel in this role, you will more than likely have:

Hold a Third Level Degree in a Science/Technical or related discipline.

Possess 5+ years of experience in a Quality Role within a pharmaceutical manufacturing facility, preferably in aseptic manufacturing.

Experience with SAP, MES, and Trackwise is desirable.

Relevant experience in a quality role, preferably in a pharmaceutical manufacturing environment.

Experience leading projects, initiatives or people.

Working knowledge of regulatory and code requirements pertaining to Irish, European, and International Codes, Standards, and Practices.

Knowledge of cGMP and GDP is essential.

Proficiency in report writing, standards development, and policy writing.

Competent in using MES and SAP.

At our company, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from Ireland to the world.

Our Commitment to Ireland:

Our Company Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of the company’s top products, helping save and enhance lives in over 140 countries around the world.

The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:01/1/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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