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Job Title: APQR Specialist
Category:  Scientific (1210)
Description: 

  • The APQR Specialist is responsible for ensuring ongoing QA compliance functions are met relative to APR/PQR with the primary function of compiling, organizing, analyzing and approving information for the APRs for products manufactured or packaged by CMOs. The APQR Specialist will assist in the circulation of the completed APR for review and approval.

  • The APQR Specialist will draft the management summary statement for the Annual Product Reviews (APRs) and Product Quality Reviews (PQR). The APQR Specialist will provide support to Regulatory Affairs in collection of chemistry, manufacturing, and controls (CMC) data from Contract Manufacturing Organization (CMO).

Requirements: 

  • The APQR Specialist is responsible for ensuring ongoing QA compliance functions are met relative to APR/PQR with the primary function of compiling, organizing, analyzing and approving information for the APRs for products manufactured or packaged by CMOs. The APQR Specialist will assist in the circulation of the completed APR for review and approval.

  • The APQR Specialist will draft the management summary statement for the Annual Product Reviews (APRs) and Product Quality Reviews (PQR). The APQR Specialist will provide support to Regulatory Affairs in collection of chemistry, manufacturing, and controls (CMC) data from Contract Manufacturing Organization (CMO).

Location  Bridgewater , NJ
Minimum Experience (yrs):  3-8
Required Education:  Not Specified


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