QC Process Improvement Specialist

Sanofi Group; Waterford; On-site; EUR 42,000 - 54,000; Full time

Job summary

Sanofi Waterford is seeking a QC Business Process Specialist to join a state-of-the-art biopharmaceutical campus. The role focuses on ensuring QC compliance, driving quality metrics and leading continuous improvement initiatives in a fast-paced environment.

You will support audits, training, and cross-functional collaboration to maintain high quality standards and ensure timely closure of change controls, deviations, CAPAs and QEs.

Qualifications

• Bachelor's Degree in Science/ Engineering or equivalent.
• Minimum of 2 years’ experience in a similar or related role.
• Extensive knowledge of cGMP and GDP in a regulated environment.
• Working knowledge of quality systems in a regulated environment.
• Understand relevant quality/compliance regulations.

Responsibilities

• Raising and management and on time closure of all Quality System processes including assigned Change Controls, Deviations, CAPAs, ILIs & QEs.
• Driving of all Quality Metrics for the department.
• Forward review of Quality Metrics to ensure no over-dues.
• Procedure effectiveness and simplification and actively contribute to continuous improvement initiative.
• Ensure effective co-ordination and support for external and internal audits for the department.
• Perform critical / constructive review of procedures and practices. Identify and lead projects to make step change improvements to the department’s Quality.
• Conduct duties in a safe manner and report all safety issues or concerns.
• Support leadership team in achieving goals / tasks.
• Actively contribute to continuous improvement initiatives utilizing lean methodologies where appropriate.
• Liaise with Quality Assurance Representative to support and improve RFT in the area and Always Audit Ready.
• Ensure all required training is completed on time.
• Maintain training in critical test activities as required in the laboratory (will be defined by head of QC).
• Complete all duties as per relevant SOPs and global procedures.
• Ensure compliance to cGMP at all times.

Skills

Attention to detail

Interpersonal skills

Communication skills

Initiative

Education

Bachelor's Degree in Science/ Engineering or equivalent

Job description

Sanofi Waterford is seeking a QC Business Process Specialist to join a state-of-the-art biopharmaceutical campus. The role focuses on ensuring QC compliance, driving quality metrics and leading continuous improvement initiatives in a fast-paced environment.

You will support audits, training, and cross-functional collaboration to maintain high quality standards and ensure timely closure of change controls, deviations, CAPAs and QEs.