Computer System Validation

Computer System ValidationExperience: 5 to 10 YearsLocation: BangaloreNotice Period: Immediate to 15DaysPrimary Function of PositionThis positions primary role is to work closely with the internal IT teams and cross functional departments Business PQCSV to support computer system validation activities related to projects and change requestsEssential Job DutiesResponsible for oversight of all GxP regulated computerized systems at all applicable points of the computerized system lifecycle ensuring compliance with regulatory requirements Computer Systems Validation CSV and Lifecycle procedures with Data Integrity requirementsProvide oversight of validation activities lead the development and approval of validation documentation and risk assessments work with project teams to determine which elements should be validated and conduct impact assessment of proposed changes to computerized systemsPerform and or direct GxP computerized system validation projects in compliance with 21 CFR 820 21 CFR Part 11 Annex 11 and Data IntegrityEnsure that GxP systems meet intended uses and comply with applicable regulations current industry practices and Intuitive Surgical policies and proceduresDevelopment and approval of Validation Plans IQ OQ Protocols Trace Matrices Risk Assessments and Validation Summary ReportsEstablish validation standards develop testing protocols document test results and maintain records for later analysisDocumentation and remediation of deviations resulting from validations qualificationsProvide assistance and guidance in training coworkers on validation protocols and operating proceduresAuthor Update assigned Operating Procedures SOPs DOPs Policies validation templates to ensure compliance with Company policies and federal regulationsSupport regulatory agency inspections audits as requiredMust be familiar with cGMPs and current industry guidelinesInterfaces between various internal and external functional areas to assure successful integration and completion of validation activities in overall project schedulesMaintains awareness of regulatory requirementsUnderstanding of FDAs new guidance of CSA risk based approach validationRequired Skills and ExperienceBachelors degree BS in related field or equivalent58 years hands on experience in Computer System Validation Quality Compliance in a FDA Regulated industry Medical Device Pharma Life Sciences with a focus on GxP systemKnowledge of fundamental cGMP concepts and FDAEMA regulations QSR 21 CFR Part 820 21 CFR Part 11 and ISO 9001 StandardsStrong knowledge of FDA Regulated manufacturing processes process validation computer and equipment validation and GMPsHands on experience in EDMS Electronic Document Management system Test Management toolsUnderstanding of FDAs recent guidance on transition of CSV to CSAAbility to develop clear concise and timely oral and written reports Excellent written and oral communication skillsAbility to work on complex projects with general direction and minimal guidanceAbility to handle multiple projects and meet deadlinesAbility to manage priorities and workflow Versatility flexibility and a willingness to work within constantly changing priorities with enthusiasmPreferred Skills and ExperienceHands on experience with Microsoft word Excel PowerPoint VisioHands on experience with EDMS Electronic Document Management system Test Management tools