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.
Key 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.