QC Business Process Specialist

(2491) Genzyme Ireland Limited; 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

About the job

At Sanofi, we’re committed to providing the next-gen healthcare that patients and customers need. For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 works together at a state-of-the-art biopharmaceutical and medical device campus. Recognized through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical Center that underpin a strong commitment to health and wellbeing. To ensure the compliance in the QC Chemistry department at Sanofi are effectively maintained and enhanced. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Primary 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.

About you

• 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.

Skills and competencies

• Excellent accuracy and attention to detail.
• Excellent interpersonal skills.
• Excellent Communication skills.
• Initiative – be able to work in a self-directed manner to see issues through to completion.
• Pursue Progress.
• Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

The salary range for this position is :€48,000.00 - €64,000 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.

We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.