Quality Operations Lead Microbiology

  • 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 55,000 staff across a network of more than 1000 independent companies in over 50 countries and operating more than 900 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 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

The purpose of this job is to manage the Quality aspects of the Pharmaceutical Microbiology, Department.  The Quality Operations Leader must ensure appropriate systems and controls are implemented to facilitate both customer and quality requirements. The Microbiology team must be led, motivated and developed in the area of quality so that they are able to react effectively to the changing business needs while maintaining quality compliance.

Job Responsibilities

  • To effectively manage and report all Quality Metrics within the Microbiology team including Exceptions, CAPA’s, Change controls, SOP’s. Ensuring all actions are assigned and tracked to ensure compliance  with company metrics
  • Completion of Microbiology approval of Quality documentation e.g. Exceptions, CAPA’s, SOP’s, Quality and technical agreements.
  • Lead cross functional risk assessment as required within the team
  • Assist in problem solving within the department.
  • To 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.
  • Responsibility for managing the completion of compendia updates assessments for microbiology.
  • To provide continuous feedback to all members of the team on all items in relation to customer or Quality requirements/changes.
  • To handle all customer related query and lead the investigation of any complaint, liaising with their team to problem solve these queries if needed.
  • To lead internal and External/regulatory audits for area of responsibility, including audit preparation, area tour, support queries during the audit and follow up of actions to closure. Finalising CAPA’s and associated deadlines.
  • To represent Microbiology in the Change control Review board as required .
  • To approve and keep updated laboratory SOPs in their area of work.
  • To ensure that customer requirements are fully met and continously work to improve relationships with customers. Manage  customer business review meetings and scheduled calls.
  • To identify any opportunities for improvement of quality and customer service and lead the team to implement continuous improvement initiatives/projects.
  • To 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. 
  • Ensure that specific Quality and customer related goals are inherent in the Microbiology Organisational goals.
  • To ensure the quality of the day-to-day work of the team continues to meets company standards and for problem solving any quality issues with other members of the organisation.
  • To ensure all related documentation is completed and filed accurately, updated as required and on time in line with company procedures.
  • To communicate regularly with their team and all other ancillary groups to ensure information is transferred effectively throughout the organisation. Provide coaching and mentoring to the team as required to improve understanding and compliance in all areas of Quality.
  • To continually liaise with management, customers and other members of the organisation on any relevant problem areas or enhancements to the business.
  • To adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.

Qualifications

  • A Degree or NCEA diploma in a relevant discipline.
  • Preferably 3 – 5 years experience in a contract laboratory environment. 
  • Excellent leadership skills.
  • 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.
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