Quality Operations Specialist

  • Full-time

Company Description

Consider joining Eurofins where people are the most important element in our business.  Eurofins is a leading contract lab that provides testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide.

We currently have a Fantastic opportunity for a Quality Operations Analyst to join our Gene Therapy department in Dungarvan Co Waterford.

What can Eurofins offer you?

  • At Eurofins we offer careers not just jobs. 
  • Developmental opportunities and career progression
  • Private Medical Insurance when with the company for 2 years for all roles
  • Income protection and life assurance
  • Free parking onsite
  • Additional annual leave days with continued service
  • The opportunity to work on life saving products
  • Work-life balance
  • Sports and Social events
  • If relocating, the possibility to stay in the company house for the first two weeks of employment depending on availability. 

Job Description

The purpose of this job is to oversee the Quality aspects of the Pharmaceutical Chemistry Gene Therapy Department. The Quality Operations Analyst must ensure appropriate systems and controls are implemented to facilitate both customer and quality requirements. 

  • To effectively manage and report all Quality Metrics within the Chemistry or Gene Therapy department including Exceptions, CAPA’s, Change controls, SOP’s, ETQ, Effectiveness checks. Ensuring all actions are assigned and tracked to ensure compliance with company metrics and no overdues.
  • Monitor, track and follow up on QA metrics to ensure green and expectations exceeded.  Maintain trends to identify areas that need attention, proactively escalate trends and lead corrective actions.
  • Prepare department trend section of quarterly QA site review trend reports.
  • Completion of Chemistry approval of Quality documentation e.g. Exceptions, CAPA’s, SOP’s, Quality and technical agreements.
  • Manage Weekly internal audits and schedule and manage site horizontal and method witnessing requirements
  • Ensure processes and systems are in place to ensure that Quality/ CAPA related project work is completed as required and associated customer reports are available in a timely manner.
  • Lead internal and External/regulatory audits for department, including audit preparation, area tour, support queries during the audit and follow up of actions to closure. Finalising CAPA’s and associated deadlines.
  • Represent chemistry in the change control Review board and Equipment meeting as required. Assign and track actions as appropriate
  • Establish and manage key metrics in the areas of quality, customer satisfaction/delivery. Ensuring specific targets are set, met and any trends noticed are addressed. 

Qualifications

  • A Degree in a scientific discipline

Skills/Experience

  • Preferably 2 – 3 years’ experience in a contract laboratory environment. 
  • Good commercial awareness and business acumen.
  • Good team player, organised, accurate, have strong documentation skills.
  • 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
  • Audit experience (performing and hosting audits).
  • Data integrity in relation to Software data collection
  • Experience with root cause analysis, CAPA, trending of metrics and continuous improvement projects.

Additional Information

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.

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