Quality Assurance Specialist New Product Introduction

Job Description We are seeking a Quality Assurance Specialist to join our quality team at the Carlow facility, within the Quality Technical Transfer/Validation Team. This role will support the introduction of new products (NPI) across our vaccine and biological manufacturing operations. It is intended to complement an already strong team and requires someone who can hit the ground running, bringing demonstrable NPI quality experience from product introduction through to final market release. The successful candidate will work across three Carlow facilities, depending on project requirements, providing an excellent opportunity to broaden exposure and build capability in new product introduction and technical transfer. This position will suit a proactive individual with strong decision making, problem solving, agility, communication, and teamwork skills, who can operate effectively in a fast paced, cross functional environment.

What you will do:

• Provide quality oversight and direction for the introduction of new products and validation activities.
• Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
• Participate as a functional expert in the cross functional team responsible for introducing products at Carlow.
• Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
• Review and approve protocols and reports for technology transfer, method qualification, and method validation.
• Review documentation associated with new products, such as QC Test Specifications, BOMs, and MES documentation.
• Support deviation investigations and close out in a timely manner.
• Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements.
• Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency.
• Actively participate in Plant/Quality committees and collaborate with other site functional groups.

What skills you will need:

• Required Bachelor's degree or higher in a related Science discipline.
• 3-5 years' experience in a quality role, ideally within a pharmaceutical manufacturing environment.
• Significant demonstrable NPI quality process experience.
• Experience supporting projects from introduction through to market.
• Strong decision making and problem solving ability.
• Agile mindset with the ability to adapt to changing priorities.
• Strong communication and teamwork skills.
• Strong report, standards, and policy writing skills.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes and equipment.
• Proficiency in Microsoft Office and job related computer applications.
• Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
• Ability to work independently and take ownership of improvement initiatives with moderate guidance.
• Proven ability to drive task completion.
• Knowledge of regulatory/code requirements related to Irish, European, and international codes, standards, and practices.
• Preferred Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice).
• Strong Continuous Improvement Mindset.
• Experience or familiarity with Lean Six Sigma methodology.

Preferred Skills:

• Continuous Improvement Approach
• New Product Introduction (NPI)
• Pharmaceutical Manufacturing
• Pharmaceutical Quality Assurance
• Process Knowledge
• Process Ownership
• Regulatory Compliance
• Stakeholder Collaboration
• Sterile Filling
• Team Collaboration
• Technical Writing Documentation

Our facility in 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 an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model.

Employee Status: Regular. Relocation: No relocation. VISA Sponsorship: No. Travel Requirements: No Travel Required. Flexible Work Arrangements: Hybrid. Shift: Not Indicated. Valid Driving License: Yes. Hazardous Material(s): NA.

Job Posting End Date: 08/14/2026. 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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.