Intellectt Inc

computer system validation (CSV)

Intellectt Inc Boston, MA
Intellectt Inc

computer system validation (CSV)

Intellectt Inc Boston, MA
5 months ago 33 applicants

See who Intellectt Inc has hired for this role

Title: Computer System Validation (CSV)

Location: Boston, MA

Duration: 12 Months

Job Requirements

  • Understand and able to review vendor Qualification document packages in line with regulatory requirements.
  • Knowledge of System and Functional Risk assessment/management, defining risk mitigation plan
  • Should have good Stakeholder management skills to interact with customers, businesses, and vendors efficiently.
  • Subject matter expertise in areas such as Quality Management, Document Management, Software Development Life Cycle, Configuration Management and Change Management
  • Should have good knowledge of Chromeleon LabVantage LIMS and Scitara, should have a good understanding of Labvantage Scitara and Chromeleon integration works.
  • Should be able to validate integration between two applications (Chromeleon and Scitara)
  • Should be able to author test scripts for Chromeleon and Scitara integration.
  • Review test scripts for Labvantage LIMS, Chromeleon, SoftMax, Scitara, and Labs
  • Know how on Equipment and Instrument qualification process and regulations.
  • Knowledge of Analytical lab instruments like CDS systems, Labx instruments, and SoftMax plate reader
  • Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT, Data Privacy, Data Integrity, and Information Security
  • Ensure Compliance of Equipment in accordance with GxP regulations and customer QMS policies and procedures across the Equipment Lifecycle
  • Knowledge of various Validation tools and templates used throughout the pharmaceutical industry.
  • Knowledge and hands-on experience conducting periodic reviews.
  • Knowledge of new regulations -Enable innovations, Quality by design, CSA.
  • Technical Writing Experience
  • Basics of project-leading skills Skills:
  • Excellent communication (oral and written) and attention to detail
  • 8 to 10 years Lifesciences, should have an analytical instrument and applications exposure
  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
  • Excellent knowledge of GxP regulations, FDA, and EMEA guidelines including 21 CFR Part 11
  • Excellent knowledge of computer system validation and GAMP -5 standards

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Information Technology

  • Industries

    Staffing and Recruiting

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