QC Section Head - Tech Transfer

Recruiter
THERMOFISHER
Location
Lower Gornal
Posted
19 May 2019
Closes
21 May 2019
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job ID : 77273BR_1Location : United Kingdom - Swindon : Job DescriptionWhen you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.At our site in Swindon, ThermoFisher are forging partnerships that are transforming the industry, creating new business models between pharma companies and their pharma service providers. We are pioneering solutions that are driven by client needs, with successful recent partnerships including Flexion and Pacira.We currently offer solutions spanning the entire pharmaceutical life cycle to help pharma and biotech companies of all sizes meet their complex development and manufacturing needs at any stage or scale enabling us to deliver a combination of unrivaled quality, reliability and compliance, backed by a reputation for scientific and technical excellence.The range of services at ThermoFisher for drug substances and drug products is wider than that of any other CDMO and we offer end-to-end capabilities and expertise to take your discovery from pre-clinical and clinical development, through scale-up, all the way to commercial supply across more than 40 oral solid, sterile and softgel dosage forms.Key Accountabilities This role is an exciting opportunity for the successful applicant to assumed a pivotal Line Manger role accountable for providing Quality Control (Chemistry) support to all Tech Transfer projects across the site and will own/promote/define the systems listed as key responsibilities.Managing a team of Analytical Scientific Officers assigned to one or more QC Tech Transfer projectsJob holder will operate within the QC Chemistry organisation and the condo project Tech Transfer matrix organisationClient facing job In this diverse an challenging role your accountabilities will include but not be limited to:Hands on involvement in all aspects of the QC Tech Transfer processAct as QC SME for new QC Tech Transfer projects and for applicable capital projects (i.e. new equipment/processes)Ensure new QC analysis, analytical equipment and analytical methods are effectively and timely transferred and introduced to the site Ensure QC analytical Tech Transfers are planned, effectively tracked, monitored and achieved in accordance with agreed timelinesEnsure timely communication to clients on progress and plan adherence Ensure timely escalation and resolution of issues to QC Management and Site Leadership Team Ensure best practices are implemented and that new QC analysis, methods and technology are fit for commercial QC operationsEnsure 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 auditsManage Risk assessments and improvement programs (implement/manage - against current and future expectations)Manage completion of all QC Tech Transfer documentation to the required standard and timescalesEstablish and maintain effective communication with condo clients to ensure that the implementation of QC analysis is undertaken to match internal and external client expectationsReport status of QC analysis for Tech Transfer projects and for applicable capital projects to the sites Senior Leadership TeamEnsure own, and teams training is undertaken in a timely and GMP compliant manner before the task is undertakenMaintain an updated and compliant training matrix for the team Ensure own and teams KPI’s, plans, targets and objectives are effectively monitored and achievedAuthorize and/or prepare scientific and technical GMP documentation as requiredLead and support investigations into issue impacting analytical issues Review & approve deviation and any change proposals related to analytical issuesStaying up to date with best practice, regulatory intelligence and sharing that knowledgeAct as SME for the above with regulators / clients (i.e. key part of major audits)Support and encourage a “Quality Culture” and company 4i values Embrace “Practical Process Improvements (PPI)” initiatives to drive and deliver improvements Can act as back up for other managers in the quality organisationExperienceYou will be a flexible, highly motivated quality professional seeking a new opportunity to develop and grow your skills within a unique operating model. To be considered for this role you will ideally have experience of the Pharmaceutical industry and a strong understanding of current GMP and technical processes. In addition to this we are looking for an individual who is able to demonstrate:Science based degree e.g.. BSc or MScSubstantial experience working in a pharmaceutical QC function, preferably within a sterile manufacturing siteSubstantial experience and ‘hands-on’ knowledge of Tech Transfers and QC chemistry technologies and methodsManagement experience – ideally will have managed one or more QC chemistry labsInvolvement in capital projects (new build/refurbishment of sterile lines) would be advantageousDemonstrable audit/client facing experienceGood Collaboration, Communication and Conflict resolution skillsGood technical writing skillsWants to learn and have a natural curiosity to understand systems and processesAbility to work in a fast paced environment essentialWhen applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.The information that you have provided in your cover letter and CV will be used to assess your application.Thank you for your interest in this opportunity.

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