The candidate will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs, Health Agency regulations and all other applicable governing regulations. An expectation as part of the team will be to also drive a Quality culture for the site.

You will work with a high performing cross functional team of talent sourced from across the company and the biotechnology industry.  Together, the team will build the future through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team.

You will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role. The candidate will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required.

Our Quality Assurance group ensures all materials inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements as well as ensuring that all equipment is adequately qualified.

JOB DESCRIPTION & SPECIFIC OBJECTIVES

The Quality Assurance Specialist within our company is required to

• Work a  4 shift pattern role

• Technical knowledge of sterile manufacturing processes

• Perform  timely reviews of  batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk

• Respond quickly to unplanned events, technical issues

• Operational experience of quality systems in a dynamic manufacturing environment e.g. SAP, Trackwise, MES

• Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements

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

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

• Involved in customer complaint investigation if required

• Support the annual product quality reviews if required

POSITION RESPONSIBILITIES

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

• Understanding of sterile manufacturing operations is preferred

• Ability to learn and utilize computerized systems for daily performance of tasks

• Ability to prioritize, manage multiple tasks, and meet deadlines

• Perform  timely reviews on batch documentation ( EBR’s ) / line clearances/ 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 our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations

• Foster a culture of continuous improvement by deploying our company's MPS tools and support implementation of Model Area within operations from the start

REPORTING STRUCTURE

Reports to Quality Lead

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

Technical

• Sterile filling processes and equipment and support services experience

• Lean Six Sigma Methodology experience desired

Education

• Degree qualification or equivalent (Science, Engineering, Technical)

• Experience in Sterile Manufacturing

General

• Good organizational skills and attention to detail

• Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.

• Ability to learn and utilize computerized systems for daily performance of tasks.

• Strong influencing skills

• Demonstrable analytical and systematic problem-solving skills

People

• Focus on Customers and Patients

• Collaborate

• Act with Candour and Courage

• Make Rapid, Disciplined Decisions

• Drive Results

• Demonstrate Ethics and Integrity

Our Company is one of the country’s leading healthcare companies, having first established here 50 years ago. The company has a dynamic and inclusive team of over 4,000 employees currently working across eight locations in Ballydine, Co. Tipperary, Brinny, Co. Cork, Dunboyne, Co. Meath, Dundalk, Co. Louth, Carlow and Dublin, and, in addition, operate substantial Human Health and Animal Health businesses. 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.

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.