Job Description:

Location: West Greenwich, RI

Salary: TBD

Description: Our client is currently seeking a Quality Assurance Senior Specialist



Need a candidate with experience in QMS


Minimally with 5 years of experience with QMS executions and deviations.


This job will have the following responsibilities:

1- Quality Management Systems experience (up to and including ownership of a quality system element, implementation of a quality system element)


2- Regulatory Compliance experience (up to and including experience presenting to a regulatory authority, ensuring GMP processes are aligned to regulations)


3- Ability to coordinate with cross functional teams, ability to communicate up and down management chain
Qualifications & Requirements:

• 1- KPI data collection and analysis with presentation to leadership at management reviews
  
  
  2- Strong systems understanding (Microsoft suite, Veeva platform, Trackwise, etc.)
  
  
  3- History of general GMP execution (Deviations, Change Controls, CAPA, Disposition of Product, Regulatory Deviation Reporting, Recalls)
  
  

Contact: asheikh@judge.com


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