Quality Investigator -

at

ProPharma Group

Overland Park, KS
Full Time
3y ago

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

 This is a 6 month remote project to support deviation and investigations 

  • Provide support to clients on quality issues such as OOS results, deviations and non-conformances.
  • Provides Quality oversight of operations and data review for accuracy, completeness, and conformance to current Good Manufacturing Practices (cGMP) and company quality standards.
  • Provide training, executing audits, document creation, communication, and oversight to meet the established quality goals of the client and applicable regulations.
  • Provide assistance in performing internal and external GMP compliance audits and annual quality review.

 

Qualifications

 

  • Qualified candidates will possess a Bachelor’s degree in scientific or engineering discipline along with 5 plus years related industry experience.
  • Proficient in Microsoft Word, Excel, Power Point and Project.
  • General knowledge of quality system elements and cGMP regulations.
  • Experience providing support to clients with quality issues such as OOS results, deviations and non-conformances arise. Also, provide advisement for the implementation of proper CAPA to resolve deviations and non-conformances.
  • Ability to write and revise Standard Operating Procedures.
  • Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.

 

 

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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