Quality Auditor

Job description

Quality Auditor – Specialist role

About the Opportunity

Reporting to Quality Systems Manager, as a Quality Audit Specialist on Sanofi site, you will play an integral role within the quality system, auditing the site processes ensuring the GxP requirements as well as Sanofi global directives are met. By verifying adherence to the GxP standards, maintaining and improving the level of compliance you will drive site continuous improvement across our processes and quality systems. You will be exposed to all business areas influencing and improving quality across the site as well as growing in your role and developing your skills too.

About Sanofi Business Unit

Sanofi focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat. The Haverhill site is well located in the UK, near to Cambridge and close to London, which makes Haverhill a great location to work.

Our teams have unique skills and capabilities which have taken many years to master, including, spray drying, continuous processing and process analytical technology (PAT), as well as complex supply chain management and highly agile, secondary packaging operations dedicated to the Speciality Care portfolio. The 9 hectare site was acquired in 1982 and employees circa 300 people.

Key responsibilities

·  Developing site self-inspection program and leading site quality audits to assure compliance with relevant GxP regulations and Sanofi global requirements.
·  Driving best practice and continuous improvement by facilitating the development of appropriate corrective and preventative actions (CAPA), monitoring progression to completion and developing and delivering site GMP induction and annual GMP refresher trainings.
·  Enhancing self-inspection influence by aligning site compliance requirements to global Sanofi Management System.
·  Facilitating the site reaching and maintaining a state of inspection readiness through escalation of non-conformances, coaching cross-functional teams in best GxP practice, trending self-inspection observations and driving adequate quality culture behaviours.

About You

To excel in this role, you will need to have:

Essential requirements:

·  Qualified Lead Auditor qualifications and experience.
·  Demonstrated knowledge and understanding of cGMP, current legislation and regulations.
·  Demonstrated ability to sucessfully faciltate quality improvement work.
·  Proven understanding of quality assurance principles and elements of a quality management system.
·  Ability to influence at senior level.
·  Effective communication and active listening skills to ensure the successful outcome for self-inspection and development of appropriate CAPA and other evaluations.
·  BSc or equivalent is desirable in Science/ Engineering discipline.

What Sanofi can offer you

·  An influential, specialist role where you are instrumental in leading and developing best practice and as the organisation grows, you can too.
·  Working with dynamic multi-functional quality systems support team where you can find many ways of influencing and development.
·  We offer a generous package including flexible benefits and are committed to helping you have a healthy work-life balance throughout your career with us.
·  We have highly subsidised restaurant with free tea and coffee.

About Sanofi

Empower Life Everyday

At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.

The values we are live by are teamwork, courage, respect and integrity.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.