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Computer Systems Validation Specialist

Company: Summit Biosciences Inc.
Location: Lexington
Posted on: December 4, 2019

Job Description:

Summary:The Computer Systems Validation Specialist (CSV) will be responsible for various aspects on the regulated validation practices for computerized systems. -The CSV is considered the subject matter expert in validation requirements for computerized systems and is responsible for maintaining the validated state of assigned computerized systems. -Essential Duties:Responsible for validation principles that incorporate a balanced, risk-based approach to deploy and maintain validated computerized systems in pharmaceutical manufacturing such as: -ERP, LIMS, EDMS, TMS, QMS, CCMS, Lab Instrumentation Systems, etc.Work with internal groups to assist development and review user requirements that detail the process, scope, and business needs of the system to include flow diagrams and criticality analysisThe CSV will be responsible for the following key roles: - - -Performing risk assessments for systems - -Performing impact assessments for systems to include classification against GAMP principles - - -Reviewing change requests and test scripts - - -Drafting IQ/OQ/PQ protocols - - Drafting validation plans - - -Developing Trace Matrixes - - -Audit trail reviews -Review and assess design of enterprise system deployments and change management to ensure they meet quality policies and regulatory requirements. -Contribute to the development and maintenance of action plans and project plans for validation tasks related to enterprise systems implementationWrite and revise SOPs and Forms to accurately reflect the current validation procedures and processesSupport maintenance activities including review/approval of preventative maintenance tasks, calibration, drawing updates, related investigationsOther duties as assigned -Candidate Attributes:The Computer Systems Validation Specialist possesses these qualities:Strong interpersonal and communication skills with demonstrated ability to effectively communicate and coordinate activities with internal groups and operationsMotivated to perform work while maintaining a focus on the long-term, continuous -improvement of key systems and leadership strategiesMotivated self-starter with excellent organizational skills and attention to detailMust be flexible, adaptable, self-motivated and able to work well independently and across teams and partnersAbility to work in a lean, action oriented organization and demonstrate a strong work - -ethic.Excellent written and verbal communication skills Qualifications:BS in Computer Science, Information Systems, Biology, Chemistry, Engineering, or related field, or equivalent working experience2-5 years of hands-on experience with validating computerized systems in a pharmaceutical or other regulated environmentExperience in validation of data management and data workflow systems is desiredKnowledge and utilization of risk-based regulatory compliance standards and quality assurance within regulated industriesExpertise in requirements for 21 CFR Part 11, Data Integrity, Annex 11, Q7A requirements, and GxP and the underlying principles of each. -Expertise with Quality Systems Management processes (Change Management, Deviation, Corrective and Preventable Actions)Excellent technical writing, project management, and organizational skillsAbility to work with cross functional teams and meet performance requirementsGood interpersonal skills and the ability to work well in a team environmentQualified to work with controlled substances

Keywords: Summit Biosciences Inc., Lexington , Computer Systems Validation Specialist, IT / Software / Systems , Lexington, Kentucky

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