JT992 - SR QUALITY APPLICATIONS SPECIALIST

Quality Consulting GroupJuncos, PR
23h

About The Position

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA

Requirements

  • Requires a Bachelor degree in related area
  • 4+ years of relevant experience
  • Computer System Validation, IT systems knowledge/expertise
  • Documentation changes
  • Quality & Compliance leadership to peers
  • Availability for 1st shift

Responsibilities

  • Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
  • Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
  • Reports on the status of validation activities to fulfill regulatory requirements.
  • Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
  • Performs system administration and configuration of quality information technology systems.
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