Category
Regulatory, Quality and Clinical
Description
Key Responsibilities:
* Manage and lead the QC Chem Tech Transfer team
* Ensure new QC analysis, analytical equipment and analytical methods are effectively and timely transferred and introduced to the site
* Ensure QC analytical technology transfers are planned, effectively tracked, monitored and achieved in accordance with agreed timelines
* Ensure timely communication to clients on progress and plan adherence
* Ensure effective handover of QC analysis to commercial QC operations and that they are in a state of readiness for regulatory and third party inspections and/or audits
* Manage Risk assessments and improvement programs (implement/manage - against current and future expectations)
* Undertake audits for sites and suppliers providing QC Chemistry service
Requirements:
* Science based degree
* At least 10 years' experience working in a pharmaceutical QC function, preferably within a sterile manufacturing site
* 5-10 years' experience and 'hands-on' knowledge of Technology Transfers and QC chemistry technologies and methods
* Management experience
* Demonstrable audit/client facing experience
* Involvement in capital projects (new build/refurbishment of sterile lines)