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Irfa******
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United Kingdom
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Last Update: 22.03.2019 at 12:00
Job Type
Full Time
Start
ASAP
Duration
8 Month +
Place
Oxfordshire, England
Country
United Kingdom
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)