Shire Jobs

A.Job Description ObjectiveLabVantage Professional Services (PSO) are expanding their team to provide an increased level of Computer Systems Validation (CSV) services and solutions, to address growing customer needs. As a key member of the LabVantage PSO team, the LIMS CSV Specialist is responsible for the delivery of CSV services which may include providing advisory services consulting to LabVantage clients on CSV, creation of validation documentation and solutions aligned with relevant regulation standards, design or execution of test scripts, and continuous growth of the CSV function in PSO. As this role requires the creation of solutions that address continuously evolving regulatory guidelines, the candidate is expected to remain academically, professionally and technically up to date and consider continuous development as part of the role.B.Primary Job Objectives75%: Providing validation consulting services and project management for LabVantage software products in a customer-facing capacity over the lifecycle of the product deployment. oWorking with LabVantage customers from presale stage to understand and clarify clients’ requirements, oTurning customer requirements into the necessary validation deliverables,oPerforming gap analysis, developing validation plans, and managing customer expectations,oDelivery of high-quality validation documentation and execution of test scripts when required,oProviding validation consultancy expert advice to customers to help guide them through the validation process,oLeading cross-functional teams in the development of validation deliverables,oAnalysing testing results and determining acceptability,oReviewing, editing and approving validation documentation,oCoordinating completion and approval of all validation deliverables,oApproximate travel time for this role may be up to 15%.15%: pre-sales/marketing activities. This includes:oDiscussions with sales, PSO, and/or customers in a pre-sales situation,oIdentify opportunities for selling validation consulting services,oWork with sales to develop proposals for validation services delivery which involve cost and effort estimation and scope definition (Statements of Work),10% working with LabVantage employees and external regulatory bodies on the overall compliance strategy. This may require: oInteraction with members of Quality Engineering, Product Development, Product Marketing, Product Management, to advise, promote, and develop professional validation services internally,oActively follow updates from Regulatory Compliance organizations in order to best advise internal and external customers of changing trends and requirements, oProvide support to LabVantage internal QA team if needed, reviewing and revising system validation-related Standard Operating Procedures, Work Instructions and compliance documentation, as and when required,oProviding and delivering training and mentoring in computer systems validation to all relevant personnel,oInitiating and enforcing necessary system corrections and improvements to established systems and processes via system change controls and mitigation plans, as applicable,oReporting to management such issues as non-conforming product, conflicting priorities, and/or resources in meeting expected validation deliverables,Any other additional task relevant to the level and scope of the role as deemed by management of LabVantage. C.Desired Competencies Demonstrates a “can do” attitude, and presents themselves as an “ambassador” of LabVantage in the most professional way,Provide and work under the supervision and support of others, and embrace training and support to facilitate continuous learning of LabVantage products, services and customer satisfaction methodologies,Self-motivated with good organizational/time management skills and ability to work with minimum supervision,An ability to identify and lead a customer enquiry established whilst on site through to the sales team,Continuous development of product knowledge,A good communicator with a high level of customer focus, who enjoys personal interaction and relationship building with key customers on routine service mattersD.Job Qualifications NecessaryProven experience as a CSV specialist in a consulting organisation, In-depth knowledge of validation deliverables associated with each step of the computer system lifecycle. Thorough understanding of industry standards and applicable regulatory guidance and rules, e.g., 21 CFR Part 11, Annex 11, Annex 15, GxP, ISO/IEC/IEEEExperience with generating and reviewing validation deliverables at each stage of the computer system lifecycle, applied to commercial off-the-shelf (COTS), configurable and custom-developed software.Experience with change control processes, CAPA and Quality SystemsStrong organization and time management skills, with exceptional attention to detailCritical and analytical thinking, as well as creative problem-solving skillsSuperior written and verbal communications and presentation skills for multiple audiences including users, technical team, vendors and customer auditors.Technical writing skills in EnglishAbility to work in cross-functional teams and build consensus across diverse groups.Should possess some Project Management skills. Must have thorough knowledge of the Microsoft Office Suite with emphasis on Excel, Word, and Project.