Empower QC Systems Admin – GxP & Regulatory Support

Catalyx; Cork; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Total Rewards package

Visa assistance

Equal Opportunity Employer

Job summary

Catalyx is seeking a QC Systems Admin to join our team at our customer site in Cork. The role is to provide day-to-day Empower support, manage projects and ensure compliance with quality and regulatory requirements.

The successful candidate will work with QC teams, support regulatory audits and CAPAs, and act as Empower SME during inspections while driving continuous improvement across site and global systems projects.

Qualifications

• BSc in Science or Engineering or similar technical discipline.
• 3+ years’ experience working with Empower as an administrator, SME or key user.
• Experience supporting Empower in a regulated environment.
• Knowledge of FDA and EMEA regulatory requirements.
• Experience supporting regulatory, customer or internal audits as an SME.
• Experience with investigations, CAPAs and change control.
• Good problem-solving and analytical skills.
• Ability to work independently and manage priorities to meet deadlines.
• Good communication and stakeholder management skills.

Responsibilities

• Provide day-to-day Empower support and manage the resolution of system support tickets.
• Build and maintain Empower Master Projects, including customised fields and methods.
• Perform system review activities.
• Participate in site and global systems projects.
• Act as an Empower SME during GxP inspections, where required.
• Support the review and approval of quality investigations, CAPAs and change controls.
• Support laboratory investigations using appropriate problem-solving methodologies.
• Provide Empower training, mentoring and guidance to users as required.
• Work collaboratively with QC and cross-functional teams to resolve issues and support continuous improvement.
• Maintain compliance with company policies, procedures and applicable quality requirements.

Skills

Empower admin

Analytical skills

Stakeholder management

Problem solving

Education

BSc in Science/Engineering

Tools

Empower

Job description

Catalyx is seeking a QC Systems Admin to join our team at our customer site in Cork. The role is to provide day-to-day Empower support, manage projects and ensure compliance with quality and regulatory requirements.

The successful candidate will work with QC teams, support regulatory audits and CAPAs, and act as Empower SME during inspections while driving continuous improvement across site and global systems projects.