Computer System Validation

4 days ago

Ahmedabad, Gujarat, India Webosphere Full time ₹ 2,00,000 - ₹ 6,00,000 per year

Computer System Validation Engineer

Job Overview

We are looking for an innovative and experienced Computer System Validation (CSV) Engineer to join our team. The CSV Engineer will be joining a quality team that is validating the quality of a new software/system. You will be 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.

Experience

1-2 Years

Responsibilities and Duties

  • Preparation and review of Validation deliverables such as URS, GxP, Impact Assessment Checklist, VP, Specification documents (SDS, FRS, TS, CS), FRA, IQ Protocol & Scripts, OQ Protocol & Scripts, PQ Protocol & Scripts, DM (Data Migration) Protocol & Scripts, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist as per Webosphere CSV SOP.
  • Execution/Support in the execution of IQ, OQ, PQ, and DM test scripts on the internal as well client side.
  • Basic knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, EU Annex 11, GAMP5.
  • Coordinate with Client to carry out Validation activity of Computerized Systems and Software.
  • Responsible for achieving & maintaining the validated status of in-scope computerized systems
  • Provide guidance on CSV validation issues and discrepancies
  • Support investigation of CSV defects and quality records (deviation, CAPAs).
  • Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions.
  • Coordinating with teammates in achieving assigned tasks.
  • Issue/bug tracking, and software incident management.
  • Develop and execute test plans to ensure that all objectives are met.

  • Implement and monitor test scripts to assess functionality, reliability, performance, and

  • Coordinate and support to Quality Manager.

  • Ensure that user expectations are met during the testing process

  • Documentation adherence to internal/Client SOP and compliance.
  • Managing department functional process as specified in standard operation procedure & suggest changes if required.

Qualifications

  • Past experience writing, reviewing and executing computer validation documentation (URS, GxP, VP, Specification documents, FRA, IQ, OQ, PQ, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist)
  • Excellent written and verbal communication skills.
  • Proficiency with MS Office tools
  • Documentation management
  • Ability to work as a team player in a consulting environment
  • Knowledge of Computer System Validation.
  • Critical thinker and creative mindset – and the ability to approach a problem creatively.
  • A meticulous approach to work.
  • A team player but can work independently too.
  • Multi-tasking and time-management skills, with the ability to prioritize tasks.

  • Computer System Validation Engineer

    6 days ago

    Ahmedabad, Gujarat, India Hiring Embassy Full time ₹ 4,20,000 per year

    Computer System Validation EngineerJob OverviewWe are looking for an innovative and experienced Computer System Validation (CSV) Engineer to join our team. The CSV Engineer will be joining a quality team that is validating the quality of a new software/system. You will be responsible for oversight of all GxP regulated computerized systems at all applicable...

  • Computer System Validation Engineer

    1 week ago

    Ahmedabad, Gujarat, India Nexus pro services Full time ₹ 4,20,000 per year

    Position - Computer System Validation (CSV) EngineerSalary - 4.2LPAExperience - 1-2 YearsLocation - Ahmedabad, GujaratContact person : Working Days - Monday to Friday, 9:30AM to 7:00PMWe are looking for an innovative and experienced Computer System Validation (CSV) Engineer to join our team. The CSV Engineer will be joining a quality team that is validating...

  • Computer system Validation

    2 weeks ago

    Ahmedabad, Gujarat, India, Gujarat Veeda Lifesciences Full time

    Primary Responsibility:• To provide support for Bioanalytical systems and users.• Actively support participation in System /Software validation activity and its execution.• Responsible for IT Server and System Backup and restoration process as defined in Sops, must have knowledge documenting the activity as per above mentioned.• Weekly ,Monthly...

  • Validation Engineer

    7 hours ago

    Ahmedabad, Gujarat, India Arizona Automation & Technologies Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Are you ready to take your career to the next level inComputer System Validation (CSV)? Join us atArizona Automation & Technologies, where we ensure compliance, quality, and innovation in pharmaceutical technology.Location:PAN INDIAExperience:4-7 YearsIndustry:Pharmaceutical / Life SciencesEmployment Type:Full-timeWhat You'll Be Doing:Spearheading Computer...

  • Validation Engineer

    2 weeks ago

    Ahmedabad, Gujarat, India GAMP Services Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Company DescriptionGAMP Services is a company based in Vadodara, Gujarat, India. We specialize in providing top-notch services in the field of systems validation. Our commitment to excellence and adherence to industry standards ensure that our clients receive reliable and efficient solutions. We are dedicated to fostering a collaborative and innovative work...

  • Senior Validation

    2 weeks ago

    Ahmedabad, Gujarat, India Fact Personnel Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    We are seeking a dedicated Senior Validation position at a reputed pharmaceutical organization based in Ahmedabad.Experience : 5+ YearsQualification : B.PharmaRole & responsibilitiesThermal mapping for mixing/holding vessels, steam sterilizers (autoclaves), terminal sterilizers, depyrogenation tunnels, lyophilizers, filling machines, cold rooms, and...

  • Data Validation

    4 days ago

    Ahmedabad, Gujarat, India Adani Enterprises Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    SAP & Invoice Data Validation & Quality Control: Inspect and validate material master data to ensure compliance with internal standards and regulatory requirements. Stakeholder Communication: Collaborate with suppliers, procurement teams, and internal departments to gather, verify, and update material information. Data Accuracy & Duplication...

  • Validation Engineer

    2 days ago

    Ahmedabad, Gujarat, India Kashiv BioSciences LLC. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    :Greetings from Kashiv BiosciencesWe are looking for Qualification, Validation and QMS Engineer for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities.Roles and ResponsibilitiesResponsible for Engineering compliance, Equipment Qualification, Validation and QMS activity.Timely...

  • Senior Embedded Hardware Engineer

    2 weeks ago

    Ahmedabad, Gujarat, India Sahana System Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Summary:We are seeking an experienced and innovative Senior Embedded Hardware Engineer to lead the design, development, and validation of complex embedded hardware systems. You will play a key role in architecting and implementing hardware solutions for products ranging from embedded IoT devices to high-performance embedded systems. This role requires...

  • Lead - Computer Vision

    2 weeks ago

    Ahmedabad, Gujarat, India Mantra Softech Full time ₹ 12,00,000 - ₹ 30,00,000 per year

    We are seeking a highly experienced Lead Computer Vision to spearhead the research, architecture, and productization of AI-based video analytics and biometric solutions.This role demands deep expertise in Computer Vision, Deep Learning, Edge AI, Linux, and GStreamer frameworks for developing intelligent camera-based systems used in identity, security, and...