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GxP System Specialist Team Lead

  • American Regent, Inc.
  • New Albany, OH, USA
  • Aug 02, 2020

Job Description

American Regent, Inc. seeks GxP System Specialist Team Lead in New Albany, Ohio. Responsible for generating, reviewing & remediating comp syst validation protocols to ensure all regulatory req'mnts are met. Undertake a wide range of duties relating to the leadership of proj's. Responsibilities incl but not limited to: planning, execution, monitoring, controlling & delivery of proj's. Will work closely w/ members of GxP team, IT, QA Compliance team & Sr Mgmt. Req's limited domestic & international travel to office & plant sites. Bachelor's in any field & 7 yrs exp working w/ GxP comp systs in pharmal or sim. reg. industry; & 2 yrs exp mng'g or supervising comp syst specialist teams. Must have following skills: Demonstrated ability to describe working w/ softw & tchnlgy infrastructure w/in lab, clinical trial co., or GMP manufact. facility & discuss how regs (like 21 CFR Part 11, 210, & 211) dictate softw creation, testing, & implementation for syst's used in these environs; Demonstrated ability to describe appropriate Quality Systs & current Good Manufact. Practice (cGMP) req'mnts (FDA, EU, ICH) w/ ability to assess compliance risks, such as speaking to guidance like GAMP 5 (FDA) or Annex 11 (EU) & discussing how massive docs break down preferred way to mng softw at GMP-regulated facility, incl ability to tie specific softw req'mnt docs to specific types of softw testing; Demonstrated ability to provide oversight in implementing & maintaining GxP comp systs in validated state; Demonstrated ability to effectively discuss core principles of validation methodology & softw dvlpmnt lifecycle (SDLC), such as req'mnts gathering, test cases & strategy, consistent dvlpmnt strategy, standard implementation process, support, updates, etc.; Demonstrated ability to resolve conflicts & disputes on regulatory compliance issues. Employer will accept any amount of prof'l exp w/ req'd skills. To apply, write job code GPSSTL on resume & email: hr@americanregent.com. Resume must ref. job code GPSSTL.
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