Sr CSV Consultant

1 month ago

Tarrytown, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • ct in the Computerized Systems Validation Leadership role on various company projects immediate focus will be on periodic reviews of the current validated state of the computerized systems in production.
  • The reviews may include inspection of the documentation related to the initial system validation, change controls, relevant CAPA activities (tracking and closure of the open system issues), backup and recovery activities, proper implementation of system administration SOPs, etc.
  • Report on the review findings, and work with the management to improve the process based on the findings and observations (e.g., identify and communicate trends, propose resolution that may include procedural documentation updates (SOP, templates, etc.) or training, etc.)
  • The job is expected to involve typical CSV Leadership responsibilities on various projects.
  • s a project CSV Lead, define release validation strategy based on the company procedural framework, author the typical validation and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, URS/FRS, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and scripts, Testing Defects, etc.

  • Clinical Study Manager

    2 weeks ago

    Tarrytown, United States Actalent Full time

    Role: Sr. Clinical Trial Manager (Therapeutic Area: General Medicine)Company : This opportunity is with a multi-billion dollar company who is currently leading the industry with 9 marketed drugs and a robust pipeline containing multiple trials in phases I-III. In addition, 100% of their drug candidates are invented and developed in house! Summary: The Senior...

  • Clinical Study Manager

    2 days ago

    Tarrytown, United States Actalent Full time

    Role: Sr. Clinical Trial Manager (Therapeutic Area: General Medicine)Company : This opportunity is with a multi-billion dollar company who is currently leading the industry with 9 marketed drugs and a robust pipeline containing multiple trials in phases I-III. In addition, 100% of their drug candidates are invented and developed in house! Summary: The Senior...

  • Clinical Study Manager

    3 weeks ago

    Tarrytown, United States Actalent Full time

    Role: Sr. Clinical Trial Manager (Therapeutic Area: General Medicine) Company : This opportunity is with a multi-billion dollar company who is currently leading the industry with 9 marketed drugs and a robust pipeline containing multiple trials in phases I-III. In addition, 100% of their drug candidates are invented and developed in house! Summary: The...

  • Clinical Study Manager

    13 hours ago

    Tarrytown, United States Actalent Full time

    Role: Sr. Clinical Trial Manager (Therapeutic Area: General Medicine) Company : This opportunity is with a multi-billion dollar company who is currently leading the industry with 9 marketed drugs and a robust pipeline containing multiple trials in phases I-III. In addition, 100% of their drug candidates are invented and developed in house! Summary: The...

  • Senior/Mechanical Engineer

    2 weeks ago

    Tarrytown, United States SGA Full time

    Software Guidance & Assistance, Inc., (SGA), is searching for a Senior Engineer for a CONTRACT assignment with one of our premier Industrial Technology clients in Spartanburg, SC . Due to client restrictions- unable to sponsor or work with 3rd party employers Responsibilities : The Sr Engineer Mechanical designs functional, reliable and cost...