Reporting to local Eurofins Leadership, the function of this role is to provide services to the client, at their facilities, to test and validate LIMS to ensure they meet the required specifications and comply with industry standards and regulations.
Job Responsibilities
- Designs and executes test plans for the Laboratory Information Management System (LIMS)
- Develops validation protocols
- Prepares the associated documentation and reports to support system implementation and regulatory submissions
- Works closely with cross functional teams, including software developers, laboratory personnel and QA team members to identify and help resolve system issues.
- Ensures all validation activities adhere to GMP and GLP requirements.
- Performing other ad hoc tasks and duties that may be required in order to perform the role.
- Science degree in a relevant discipline
- 3 to 5 years’ experience with associated Computer Validation, or IT qualification within the pharmaceutical industry, in particular with validation principles and processes of LIMS.
- Strong understanding of and practical experience of LIMS functionalities and laboratory environments / workflow in a GMP and GLP space.
- Proficient in Computer System Validation (CSV) processes and software testing methodologies.
- Expertise within GxP regulatory requirements
- Able to analyse complex systems and data to identify issues and develop effective solutions.
- Excellent reasoning skills to investigate and trouble shoot problems and make sound decisions based on data and analytical findings
- Demonstrated computer skills – requires excellent MS Office experience (especially advanced Excel, Outlook)
- Demonstrated ability to plan, multi task and prioritise
- Demonstrated teamwork, communication (written & verbal), and organisational skills
- Proven ability to work independently coupled with mature collaboration skills
- Ability to meet deadlines consistently
- Very strong analytical skills
- Positive attitude and sense of urgency
- Ability to take complex concepts and reduce them to step by step plans and actions, and help others do the same
- Excellent client service skills, attention to detail, and persistence.
Proficient in English; proficiency in other European languages is an advantage.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 62,000 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.
