Computer System Validation

3 hours ago

Bengaluru Karnataka India, Karnataka LTIMindtree Full time

Computer System Validation

Experience: 5 to 10 Years

Location: Bangalore

Notice Period: Immediate to 15Days



Primary Function of Position

This 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 requests


Essential Job Duties

  • Responsible 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 requirements
  • Provide 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 systems
  • Perform and or direct GxP computerized system validation projects in compliance with 21 CFR 820 21 CFR Part 11 Annex 11 and Data Integrity
  • Ensure that GxP systems meet intended uses and comply with applicable regulations current industry practices and Intuitive Surgical policies and procedures
  • Development and approval of Validation Plans IQ OQ Protocols Trace Matrices Risk Assessments and Validation Summary Reports
  • Establish validation standards develop testing protocols document test results and maintain records for later analysis
  • Documentation and remediation of deviations resulting from validations qualifications
  • Provide assistance and guidance in training coworkers on validation protocols and operating procedures
  • Author Update assigned Operating Procedures SOPs DOPs Policies validation templates to ensure compliance with Company policies and federal regulations
  • Support regulatory agency inspections audits as required
  • Must be familiar with cGMPs and current industry guidelines
  • Interfaces between various internal and external functional areas to assure successful integration and completion of validation activities in overall project schedules
  • Maintains awareness of regulatory requirements
  • Understanding of FDAs new guidance of CSA risk based approach validation



Required Skills and Experience

  • Bachelors degree BS in related field or equivalent
  • 58 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 system
  • Knowledge of fundamental cGMP concepts and FDAEMA regulations QSR 21 CFR Part 820 21 CFR Part 11 and ISO 9001 Standards
  • Strong knowledge of FDA Regulated manufacturing processes process validation computer and equipment validation and GMPs
  • Hands on experience in EDMS Electronic Document Management system Test Management tools
  • Understanding of FDAs recent guidance on transition of CSV to CSA
  • Ability to develop clear concise and timely oral and written reports Excellent written and oral communication skills
  • Ability to work on complex projects with general direction and minimal guidance
  • Ability to handle multiple projects and meet deadlines
  • Ability to manage priorities and workflow Versatility flexibility and a willingness to work within constantly changing priorities with enthusiasm




Preferred Skills and Experience

Hands on experience with Microsoft word Excel PowerPoint Visio

Hands on experience with EDMS Electronic Document Management system Test Management tools

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