Quality Systems Manager

  • Full-time

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Eurofins BPT facility are currently recruiting for a Quality Systems Manager on a full time permanent basis.

The responsibility of the Quality Systems Managers is to ensure that the quality system is appropriate to the needs of the site and that it is rigorously implemented, and compliant to the various standards to which the sites operate.

 

-         Responsible for development of direct reportees, driving progression, training and improvement of processes within the team.

-         Ensure the Team are cross trained adequately to ensure all functions are resourced adequately.

-         Develop and Maintain Quality System metrics ensuring regular reporting of metrics and escalation of issues to management

-         Driving quality system improvements to maximise the potential of the sites as a first class partner to our clients.

-         Responsible for the compliance of the quality system to the various standards and directives to which the sites operate – cGMP etc.

-         Design and continuous improvement of the quality functions, including internal audits, supplier quality management, change control, documentation control, deviations, quality of data, QA batch release and electronic systems.

-         Review of the quality system and scheduling, chairing and implementing the actions from quality reviews.

-         Responsible for Managing client audits and regulatory inspections, managing CAPA and all correspondence to the client or regulator in this regard.

-         Responsible for management of requests from clients including technical agreements received from clients.

-         Responsible for maintaining the controlled substance licence status and complying in full with the requirements for possession of controlled substances.

-         Be the management representative for the regulatory bodies, and the point of contact for informing them of any site changes or variations to licences or certificates.

-         Keeping up to date with regulatory updates and applying those updates to the quality systems and providing training / briefs to others necessary.

 

Experience & Qualifications

 

-         A qualification to degree level in a science discipline is preferred.

-         A qualification in Quality Assurance, including internal auditing is preferred

-         Experience within a laboratory / QC environment

-         At least 7 years within a QA role, preferably with 2 of those at management level

-         Good knowledge of standards and regulations – ISO 17025, EU and US GMPs, ICH

-         Ability to work independently or as part of a team.

-         Excellent report writing, communication and organisational skills.

-         Quality oriented with the ability to consistently work to industry and client standards.

-         Positive and tenacious approach to work.

-         Highly organised, methodical and systematic approach to work.

-         Passionate about quality and customer service.

-         Good communication skills both internally and externally. Ability to understand customers’ requirements and to be able to devise and articulate the most appropriate solutions.

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