QA Operations Manager
Job ID : 88024BRLocation : 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 Manage and lead the QA Operations department and all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee developmentResponsible for resource management and for initiating timely resource planning for the QA Ops team based on production forecasts and business needsProvide QA oversight, technical expertise and leadership across all aspects of product manufacturing from raw materials, through warehouse activities, engineering, quality control, manufacturing and operations supportMonitor and oversee the batch record review process, including escalation of issues and driving completion of quality records e.g. Deviations, Investigations, CAPA and Change ControlsDrives and owns “Quality on the Floor” facilitating the desired ‘way of working’, quality culture and the 4i values through actions, coaching and mentoringManage completion of GMP documentation to the required standard and timescales, to ensure timely and efficient service for our internal and external clientsPrepare quality documents e.g. SOPs, technical documents, undertake investigations, review and approvals e.g. Change Controls, Deviations and ComplaintsEnsure new products, equipment and processes are effectively introduced to internal & external standardsProactively drive and react to system trending (e.g. deviations, complaints) to ensure ongoing quality performance.Act as QAOps representative during Regulatory Inspections and audits (e.g. client and corporate)Ensure own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved. Including standard lead-times and supporting the Business goals for e.g. RFT and OTD/ OTIFEmbrace and actively drive Practical Process Improvements (PPI) and performance by identifying opportunities to improve quality/compliance, reduce cycle time, reduce COGs, and increase operational efficiency. Partner with key stakeholders to prioritize projects aligning with the quality goals and objectivesEnsure that own, and teams work complies with GMP, Data Integrity & Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’s, BMR’s, Protocols, Guidance’s, etc.Ensure own, and teams training is undertaken in a timely and GMP compliant manner before the task is undertaken and maintain an updated and compliant training matrix for the teamMaintain thorough understanding of international regulatory guidance, ISO, corporate and client requirements pertinent to the site, and to ensure that all work within the Quality department and across the aligned cell complies with these and with departmental proceduresDeliver effective leadership and communications in line with company rules, policies and proceduresCan 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:Minimum Degree in Chemistry, Pharmacy or Microbiologyexperience in acting and executing ‘Qualified Person’ responsibilities and duties as defined in 2001/83/EC and 2001/82/EC (as amended)Must have substantial experience working in a pharmaceutical quality function within a sterile manufacturing site , experience with Cephalosporins/Penicillin is preferableMust be up to date knowledge of the principles and guidelines for GMP as set out in: UK “Orange Guide”, EU “Eudralex Volume 4”, U.S. “CFRs” and other relevant regulations.Excellent scientific and technical knowledgePre-requisite for this job is that the candidate is not on the “FDA DEBARMENT LIST”When 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.