Note: The job is a remote job and is open to candidates in USA. Codon Partners is supporting a pharmaceutical company seeking an experienced Quality Assurance Consultant for a part-time engagement. The role provides hands-on Quality oversight across late-stage and commercial manufacturing programs, including technology transfer, process qualification, batch record review, batch disposition, and external manufacturing oversight.
Responsibilities
- Review and approve manufacturing and validation protocols
- Review and approve final technical and Quality 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 Quality records associated with manufacturing programmes
- Provide Quality oversight for technology transfer and manufacturing activities performed by external manufacturing partners
- Partner closely with Manufacturing, CMC, Technical Operations and external CDMO teams
- Ensure manufacturing activities and associated documentation remain compliant with applicable GMP requirements
Skills
- We are looking for an experienced pharmaceutical Quality professional 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 commercial batch release
- • Deviations, investigations, CAPAs and change controls
- • CMO/CDMO or external manufacturing oversight
- 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
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