Product Quality Specialist

Description:

Provide product quality oversight for new product development from ideation to regulatory approval across global markets. Lead initiatives to ensure GMP and GDP compliance throughout the supply chain.

Reports To

Senior Director of Clinical Operations

Responsibilities & Duties

• Lead product quality continuous improvement internally.
• Develop, review and approve product quality documents including batch manufacturing records, analytical methods and quality records to support new product submissions.
• Provide quality support for external manufacturers in generating validation and stability protocols.
• Generation and approval of Quality Technical Agreements for outsourced activities.
• Issue annual internal and external audit schedules.
• Investigate product deviations and out of specifications.
• Assist with periodic regulatory reporting. 
• Complete vendor management assessments and audits.
• Support with regulatory or customer quality audits. 
• Preparation of corrective and preventative actions (CAPAs). 
• Documentation approval on the eQMS system.
• Completion and approval of change controls, deviations, investigations, risk assessments, as required. 
• Support in roll out of quality training on site. 

Qualifications and Experience

·        Batchelors Degree in Quality, Good Manufacturing Practice, Pharmaceutical technology or other science-based discipline. 

·        5 years + experience in the pharmaceutical quality environment. 

·        Project management experience an advantage.