Pharmaceutical Quality Compliance Specialist

Boston, MA

Job ID: 131337 Industry: Pharmaceutical

 

Pharmaceutical Quality Compliance SME

Environment:

Our client is a Pharmaceutical company in need of a Quality Compliance Specialist to support the Oncology and Biologics group.

Job Duties/Responsibilities:

Our client is looking for a Quality Compliance Specialist to support projects and initiatives within the their designated group, ensuring compliance with GxP regulations and technical agreements. This person will be responsible for driving successful regulatory visits, both internally and externally, by managing pre-inspection activities and coordinating post-inspections activities. This person will be responsible for conducting analysis on quality metrics to identify risk as well as driving resolutions. This person will be overseeing any CAPAs resulting from inspection readiness activities and maintaining the Supplier Qualification Program. This person will be working cross-functionally between Quality, Regulatory Affairs and CMOs. This person will also be responsible for writing new procedures and revising existing ones as well as providing information for APRs and Periodic Product Reviews.

Required:

Pharmaceuticals

Quality/Compliance

cGMP regulations for US & EU markets

Inspection Readiness Experience

Excellent soft skills

Job Type: Contract 

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