Quality Associate

PE Global (UK); Cork; On-site; EUR 55,000 - 75,000; Full time

Job summary

PE Global (UK) in Cork, Ireland seeks an Operations Coordinator to support Process Team Leads across Commercial and Clinical products, while managing ERP transactions for CMOs and ensuring accurate work orders and PO receipts.

The role emphasizes QMS change controls, KPI consolidation, and cross‑functional problem solving, with a commitment to continuous improvement and cost savings.

Qualifications

• Minimum 5 years’ experience in operations in a regulated environment.
• Proficiency with ERP systems such as SAP.
• Strong communication and organizational skills.
• Ability to engage cross-functional teams to resolve issues.
• Experience with lean/six sigma/continuous improvement tools.

Responsibilities

• Provide direct support to Process Team Leads across Commercial & Clinical products.
• Manage ERP transactions for production at CMOs, including receipting POs and inter‑org transfers.
• Own and manage change controls and deviations within the QMS with on‑time closure.
• Consolidate and issue key performance metrics for the Process Team.
• Provide back‑up support during holidays and peak periods.
• Drive continuous improvement initiatives with measurable time and cost savings.
• Perform cross‑functional root cause analysis and implement corrective actions.
• Document key business processes using SOPs or Best Practice documents.
• Execute operation tasks to reduce touchpoints where possible.

Skills

ERP systems

Cross-functional teamwork

Lean Six Sigma

Communication skills

Independence

Education

Relevant 3rd level qualification

Tools

SAP

Job description

Key Responsibilities

• Provide direct support to Process Team Leads across Commercial & Clinical products (Small Molecules, Biologicals, Drug Substance, Drug Product and Packaging operations on targeted/prioritized activities.
• Manage and execute all transactional ERP aspects for production efforts at CMOs (includes executing production transactions, updating work order dates, receipting of purchase orders, inter organizational transfers etc.)
• Own and manage prioritized change controls and deviations within the Quality Management System (QMS) to effective on time closure and no impact on supply.
• Consolidation and issuance of key performance metrics per Process Team
• Provide back-up support for Process Team Leads where necessary (e.g. holidays)
• Support selected continuous improvement activities aligned to the site business plan objectives with clear and measurable time and money savings.
• Work cross-functionally to perform rigorous root cause analysis, to understand issues and implement corrective actions as appropriate.
• Document key business processes in a standard format (e.g., Best Practice Document or Standard Operating Procedure).
• There may be a need for this person to execute operation tasks with a view to eliminating or reducing the number of touchpoints associated with a task.
• This list of support responsibilities may change depending on business needs and employees are expected to be adaptable and flexible where this need arises.

Experience & Skills

Minimum requirement of 5 years’ experience within an Operations and regulated environment.

Relevant 3rd level qualification.

Required skills needed to accomplish the responsibilities/essential functions include:

• Will have a working understanding of ERP systems (e.g. SAP)
• Will have a good working understanding of the processes/unit operations assigned to the team.
• Ability to engage cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.
• Experience in lean/six sigma/continuous improvement tools and techniques.
• Excellent written and verbal communication skills.
• A high level of initiative and drive, as well as excellent organizational skills, are key role requirements.
• Ability to work independently.