Quality Operations Lead (Chemistry)

  • Dungarvan, Co. Waterford, Ireland
  • 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

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 have a fantastic opportunity for a Quality Operations Lead to join our chemistry department in Dungarvan Co Waterford

 

The purpose of this job is to manage the Quality aspects of the Pharmaceutical Chemistry, Department.  The Quality Operations Leader must ensure appropriate systems and controls are implemented to facilitate both customer and quality requirements. The Chemistry department 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.

 

-         To effectively manage and report all Quality Metrics within the Chemistry 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.

-         Lead and schedule cross functional risk assessment (RCA) as required within the department.  

-         Assist in problem solving within the department.

-         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.

-         Responsibility for managing the completion of compendia updates assessments for Chemistry.

-         Provide continuous feedback to all members of the department on all items in relation to customer or Quality requirements/changes.

-         Handle all customer related query and lead the investigation of any complaint, liaising with their department to problem solve these queries if needed.

-         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.

-         Effectively manage and report all Quality Metrics within the Chemistry 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.

-         Lead and schedule cross functional risk assessment (RCA) as required within the department.  

-          Assist in problem solving within the department.

-         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.

-         Responsibility for managing the completion of compendia updates assessments for Chemistry.

-         Provide continuous feedback to all members of the department on all items in relation to customer or Quality requirements/changes.

-         Handle all customer related query and lead the investigation of any complaint, liaising with their department to problem solve these queries if needed.

-         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

-         Approve and keep updated laboratory SOPs in their area of work.

-         Ensure that all analysts are trained and have completed training records for all tests and other training completed.

-         Ensure that customer requirements are fully met and continously work to improve relationships with customers. Manage  customer business review meetings, inclduing meeting  lead, preparing slides and trends and attend scheduled calls.

-         Identify any opportunities for improvement of quality and customer service and lead the relevant team to implement continuous improvement initiatives/projects.

-         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 departments Organisational goals.

-         Ensure the quality of the day-to-day work of the department continues to meet company standards and for problem solving any quality issues with other members of the organisation.

-         Ensure all related documentation is completed and filed accurately, updated as required and on time in line with company procedures.

-         Communicate regularly with their department and all other ancillary groups to ensure information is transferred effectively throughout the organisation. Provide coaching and mentoring to the department as required to improve understanding and compliance in all areas of Quality.

-         Continually liaise with management, customers and other members of the organisation on any relevant problem areas or enhancements to the business.

-         Adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.

-         Lead according to Eurofins leadership charter and act as a role model for leadership.

 

Experience & Qualifications

-         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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