Skip to content

This website works best using cookies which are currently disabled.Cookie policy  Allow cookies
JobServe
 

Job Application

 
 
 

Please answer the following questions in order to begin the process of your application.

 
 
Email Address *
 
I certify that I am a U.S. citizen, permanent resident, or a foreign national with authorization to work in the United States. *
 
 
 
File Attachments:
(2MB file maximum. doc, docx, pdf, rtf or txt files only)
 
Attach a Resume * 
 
 
 * denotes required field
 
 
 

Key Privacy Information

When you apply for a job, JobServe will collect the information you provide in the application and disclose it to the advertiser of the job.

If the advertiser wishes to contact you they have agreed to use your information following data protection law.

JobServe will keep a copy of the application for 90 days.

More information about our Privacy Policy.

 
 

Job Details

 

GxP System Specialist Team Lead (Full Time)

Location: New Albany, OH Country: United States of America
 
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 years exp working w/GxP comp systs in pharmal or sim. reg. industry; & 2 years 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 life cycle (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: (see below) Resume must ref. job code GPSSTL.


Posted Date: 02 Aug 2020 Reference: JS065249NEWALBANYOH Company: American Regent, Inc. Contact: