Overview Role Title: Process Support Specialist Location: Carlow, Ireland Job Purpose: The IPT Process Support Specialist is responsible for generating, reviewing, and expediting GMP-related documentation, including Quality Notifications, CAPA close-outs, Standard Operating Procedures (SOPs), Standard Work Instructions (SWIs), and change controls.
The role ensures compliance, operational efficiency, safety, and reliable product supply within a pharmaceutical manufacturing environment.
Responsibilities Support manufacturing operations by generating GMP documentation, investigating equipment and process issues, and completing quality notifications.
Serve as a document system expert, managing document review, approval, and workflow, including SOPs, SWIs, training documents, and change controls.
Support batch release activities through timely completion of Quality Notifications, interim/summary reports, and documentation to meet release requirements.
Raise and investigate CAPAs, quality notifications, and customer complaints using standard tools (FMEA, Fishbone, 5 Whys), and implement corrective actions via the change management system.
Assist with training management and provide guidance to the team as required.
Ensure compliance with global policies, procedures, regulatory requirements, and GMP in all daily activities.
Contribute to a safe, compliant, and continuous improvement culture.
Perform other duties as assigned to support manufacturing and quality objectives.
Skills & Knowledge Education & Experience Bachelor's degree or higher in Science, Engineering, or a related technical discipline preferred.
Relevant experience in manufacturing, preferably in a GMP-regulated environment.
Technical Competencies Experience with SAP and Microsoft Office applications.
Knowledge of Irish, European, and international regulatory requirements and standards.
Experience in equipment and process validation.
Understanding of sterile filling processes and associated equipment.
Familiarity with Lean Six Sigma methodology is desirable.
Strong report, policy, and SOP writing skills.
Business Competencies Excellent communication, presentation, and interpersonal skills.
Ability to understand cross-departmental business processes and provide operational support.
Teamwork and coaching abilities, including training and facilitation skills.
Strong analytical, problem-solving, and risk management skills.
Flexible, organized, detail-oriented, and goal-driven with effective time management.
Leadership Competencies Customer and patient-focused mindset.
Collaboration and teamwork.
Integrity, ethics, and accountability.
Ability to make disciplined decisions and drive results.
Talent development and coaching skills.
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