Quality Systems & Process Specialist

Sanofi Group; Waterford; On-site; EUR 48,000 - 64,000; Full time

Job summary

Sanofi Waterford is seeking a Quality professional to ensure compliance and continuous improvement within the QC Chemistry department. You will manage Change Controls, Deviations, CAPAs, and Quality Metrics while supporting internal and external audits and maintaining cGMP standards.

The role requires a science/engineering background, 2+ years of relevant experience, and a strong understanding of GDP and quality systems in regulated environments.

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

Initiative

Progress mindset

Quality awareness

Education

Bachelor's Degree in Science/Engineering or equivalent

Job description

Sanofi Waterford is seeking a Quality professional to ensure compliance and continuous improvement within the QC Chemistry department. You will manage Change Controls, Deviations, CAPAs, and Quality Metrics while supporting internal and external audits and maintaining cGMP standards.

The role requires a science/engineering background, 2+ years of relevant experience, and a strong understanding of GDP and quality systems in regulated environments.