Computer Systems Validation
3 weeks ago
DESCRIPTIONResponsible for the continued compliance and further expansion of the TransPerfect corporate Quality Management Systems (QMS) in the area of Computerized Systems Validation within the Trial Interactive division and consulting to other TransPerfect divisions as needed. This includes, but is not limited to, the following areas:Software Development Life CycleCommercial off the shelf (COTS) Validation and subsequent 3rd Party Vendor QualificationInfrastructure QualificationRegulatory Compliance EvaluationsValidation Package Reviews/ApprovalsOperational ReadinessPeriodic ReviewsChange Control-Investigate validation-specific complaints or adverse experiences and operational problems to identify root cause and effective corrective and preventive actions; provide the formal Client Escalation Report back to the client-Actively maintain and improve colleagues’ awareness of Systems Validation processes, policies, and procedures through training and any other methods-Travel up to 20% domestically and internationally as required-Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor
REQUIRED SKILLSExperience with study documentation for clinical developmentKnowledge of eClinical technologiesAbility to adhere to and abide by the company’s quality standardsExceptional problem solving/critical thinking skills and ability to learn new skills quicklySuperior organizational and multi-tasking skills in order to meet commitments and deadlinesSuperior written and spoken communication skills in EnglishProficiency in Microsoft Office (Word, Excel, Outlook Powerpoint)
REQUIRED EXPERIENCE AND QUALIFICATIONSMinimum Bachelor’s Degree or its equivalentMinimum of 2 years of experience in the Life Sciences industryMinimum of 3 years of experience in the Computerised System Validation
DESIRED SKILLS AND EXPERIENCEKnowledge of the latest ISO 9001 and ISO 27001 standardKnowledge of clinical development phases and processesKnowledge of regulations (e.g. FDA, EMA, MHR) and industry best practices including GxP (e.g. GCP, GMP, GDP), ICH E6 R2, 21 CFR Part 11, Annex 11, GAMP 5.Previous employment in Pharmaceutical, CRO, Medical Device, or Investigative SitePrevious experience in CAPA management and root cause investigationsFluency in a foreign languageAble to multitask in a fast-paced environmentWork well with people from a variety of different backgrounds and culturesBuild relationships with co-workers from a variety of teamsCan work independently and as part of a team
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