Quality Systems Specialist

Prochem Engineering; Munster; On-site; EUR 55,000 - 85,000; Full time

Job summary

Prochem Engineering seeks a Quality CI Specialist to drive digital transformation in a GMP-regulated environment. You will lead cross-functional teams to identify and implement quality improvements, monitor metrics, and ensure root-cause analysis for preventive actions.

The role emphasizes leading continuous improvement projects, collaborating with production, and maintaining records to report progress to stakeholders. Strong planning, communication, and adaptability are essential.

Qualifications

• Third level qualification (degree in science or related discipline).
• Minimum 2/3 years’ experience in a similar role Pharmaceutical or sterile Manufacturing experience would be an advantage.
• Very good knowledge of cGMP in a regulated environment.
• Excellent accuracy and attention to detail.

Responsibilities

• Holding the role of CI Specialist according to SMS 2.0 definition and standards.
• Facilitating cross-functional teams to identify quality improvement opportunities and implement solutions.
• Monitoring and analyzing quality metrics to identify trends and areas for improvement.
• Contributing to quality issues investigations to identify the underlying root cause and define the appropriate preventive actions.
• Leading and managing continuous improvement projects using the appropriate methodologies.
• Collaborating with production teams to implement process improvements.
• Supporting the implementation of new quality systems and tools.
• Measuring the effectiveness of improvement initiatives implemented and defining remediation action when necessary.
• Maintaining records of improvement activities and reporting on their progress to stakeholders.
• Fostering a culture of continuous improvement within the organization.

Skills

Quality Improvement

Project Management

Data analysis

Interpersonal skills

Communication

Planning and organizing

Self-motivated

Adaptability

Education

Science degree or related discipline

Tools

Computer systems

Job description

Role Purpose

Quality Project Excellence Team comprises of required number of team members sufficient to support ongoing projects, and are part of Sanofi Waterford Quality Department.

Purpose: To drive organizational transformation by Simplifying and standardizing processes, improvement on cycle times through performance initiatives and implementing risk-based approaches in all quality Continuous Improvement processes.

Mission:

• Support the transition from paper-based to digital for Sanofi Waterford.
• Focus on AI-driven tools to make better, data-driven decisions more quickly.
• Right first-time principle in the execution and delivery of all projects.

Duties

• Holding the role of CI Specialist according to SMS 2.0 definition and standards
• Facilitating cross-functional teams to identify quality improvement opportunities and implement solutions
• Monitoring and analyzing quality metrics to identify trends and areas for improvement
• Contributing to quality issues investigations to identify the underlying root cause and define the appropriate preventive actions
• Leading and managing continuous improvement projects using the appropriate methodologies
• Collaborating with production teams to implement process improvements
• Supporting the implementation of new quality systems and tools
• Measuring the effectiveness of improvement initiatives implemented and defining remediation action when necessary
• Maintaining records of improvement activities and reporting on their progress to stakeholders
• Fostering a culture of continuous improvement within the organization
• Drive, develop, and maintain the CI Board under his/her scope
• Establish and prioritize quality initiatives for the area in scope
• Advise on best practices for quality management and continuous improvement
• Advise production teams on process improvement strategies
• Inform teams about best practices and their benefits

Qualifications and Experience

• Third level qualification (degree in science or related discipline)
• Minimum of 2/3 years’ experience in a similar role Pharmaceutical or sterile Manufacturing experience would be an advantage.
• Very good knowledge of cGMP in a regulated environment.
• Excellent accuracy and attention to detail.
• Strong Planning/Organising skills.
• Proven and effective Project Management skills.
• Customer Focus Driven with excellent interpersonal skills.
• Excellent communicator with Good Presentation skills.
• Working knowledge of computer systems.
• Personal development and goal management skills.
• Flexible and adaptable- comfortable and open to change.
• Works well across all levels of the organisation, multi-site and multi-national environment.
• Works on own initiative in a Self-Directed manner with minimal supervision.
• Highly motivated and focuses on achieving results.
• Takes personal responsibility for own development and actions.