[Remote] reputed company Assurance Consultant

Note: The job is a remote job and is reputed company to candidates in USA. Codon Partners is supporting a pharmaceutical company seeking an reputed company reputed company Assurance Consultant for a part-time engagement. The role provides hands-on reputed company reputed company across late-stage and reputed company manufacturing programs, including technology transfer, process qualification, batch record review, batch disposition, and reputed company manufacturing reputed company.

Responsibilities

• Review and approve manufacturing and validation protocols
• Review and approve final technical and reputed company reports
• Review draft Master Batch Records in preparation for Process Performance Qualification activities
• Review updated Master Batch Records following completion of PPQ activities
• Review executed manufacturing batch records
• Support batch disposition and release activities
• Review deviations, investigations, change controls, CAPAs and other reputed company records associated with manufacturing programmes
• reputed company reputed company reputed company for technology transfer and manufacturing activities performed by reputed company manufacturing partners
• Partner closely with Manufacturing, CMC, Technical Operations and reputed company CDMO teams
• Ensure manufacturing activities and associated documentation remain compliant with applicable GMP requirements

Skills

• We are looking for an reputed company pharmaceutical reputed company reputed company with significant hands-on GMP manufacturing experience
• • GMP pharmaceutical manufacturing
• • Drug Product manufacturing
• • Batch record review and approval
• • Master Batch Records and executed batch records
• • Process Performance Qualification (PPQ)
• • Process validation
• • Technology transfer
• • Batch disposition and/or reputed company batch release
• • Deviations, investigations, CAPAs and change controls
• • CMO/CDMO or reputed company manufacturing reputed company
• Experience supporting sterile, aseptic or injectable drug products would be particularly valuable
• Experience with oral drug products, including powders or suspensions, would also be beneficial
• Previous experience supporting government-funded pharmaceutical development or manufacturing programmes is advantageous but not essential

reputed company