<p>Kedrion Biopharma is seeking a Quality Assurance Officer to join the Quality department in Elstree, Hertfordshire. </p><p>The role involves supporting various departments on-site, such as Production, Engineering, and Technical, to oversee the timely resolution of quality incidents and deviations using Trackwise. Additionally, the position entails ensuring compliance with quality systems through auditing and necessary training.</p><p>As the Quality Assurance Officer, you will play a key role in promptly reviewing Batch Process Records, serving as the main QA point of contact during shifts, and conducting walk rounds in different departments to uphold quality standards throughout the facility.</p><p>This opportunity is ideal for individuals with previous experience as a Quality Assurance Officer in the pharmaceutical sector. </p><p>Kedrion Biopharma is a biopharmaceutical company headquartered in Italy, which collects and fractionates blood plasma to produce and distribute worldwide plasma-derived therapies for use in treating and preventing serious diseases, disorders, and conditions.</p><p><strong>This role is on a 24/7 shift - 4 days on, 4 off, 4 nights on, 4 off - 12 hour shifts - 7am - 7pm and 7pm to 7am</strong></p><p><strong>Our site is not easily accessible by public transport so please take this into consideration when applying as this role is fully on-site.</strong></p><p><strong>Duties & Responsibilities –</strong></p><ul><li>To be primary QA contact across site throughout shift. Being able to discern what is potentially a major or critical deviation.</li><li>Receive, review and process quality reports on Trackwise (eg DR/QI/CAPA records) according to define procedures.</li><li>Request, discuss and agree actions in response to a range of quality records including deviations, complaints and control changes as required.</li><li>Ensure that any documents presented for QA approval/checking are complete.</li><li>Ensure a standard approach to quality systems throughout the facility, by undertaking both internal quality audits and QA inspections of facilities and activities, for departments across site.</li><li>Ensure concerns regarding product safety and quality are drawn to the attention of colleagues and appropriate staff, including QA Management.</li><li>To co-ordinate and maintain the files for a range of quality records as required.</li><li>To perform QA AQL sampling for Finished Products Inspection.</li><li>Review Autoclave Batch Processing Records.</li><li>To perform regular audits of the manufacturing facility and contribute to continuous improvement activities.</li><li>To participate as required in Regulatory and customer audits.</li><li>To undertake work related to job objectives as directed by QA management.</li></ul><p><strong>S</strong><strong>kills & Education required to help you within the role – </strong></p><ul> <li>Education</li> <ul> <li>Degree level qualification in science discipline or equivalent.</li> </ul></ul><ul> <li>Essential – </li></ul><ul><li>Experience of working within regulated Quality environment.</li><li>Knowledge, understanding and experience of Quality Management Systems including CAPA’s, Deviations and Root Cause Analysis</li><li>Understanding of GMP and GxP. </li><li>Capable of entering production facility (change procedure) essential.</li><li>Competent with using root cause analysis and error risk reduction tools essential.</li></ul><ul><li>Desirable - </li><li>Knowledge of UK/EU and US Regulatory requirements desirable.</li><li>Experience of working with TrackWise and LIMs desirable but not essential.</li></ul><p>We're looking for highly motivated and experienced people to drive the business forward. If you are passionate about quality and want to work within a reputable pharmaceutical company, then we want to hear from you. </p><p><strong>In return we offer -</strong></p><ul><li>Competitive salary</li></ul><ul><li> Annual bonus scheme</li></ul><ul><li> 25 days holiday (plus bank holidays)</li></ul><ul><li> Pension</li></ul><ul><li> Life insurance</li></ul><ul><li> On-site parking</li></ul><ul><li> Employee assistance programme </li></ul><ul><li> Virtual GP </li></ul><ul><li> Cycle to work scheme</li></ul><ul><li> Subsidised canteen</li></ul><ul><li> Employee discounts and cash back</li></ul><ul><li> Gym membership discounts</li></ul><ul><li> Family friendly policies</li></ul><ul><li> Employee recognition programme </li></ul><ul><li> Loyal service awards </li></ul><p>In 2022, Kedrion joined forces with BPL (Bio Products Laboratory). Based in Elstree, BPL operates a targeted portfolio of successful plasma-derived products to treat rare diseases. There are nearly 1000 colleagues based at the campus, where a number of our life-enhancing plasma-derived products are manufactured. </p><p>With the combination of Kedrion and BPL, the company now becomes a global player in plasma derivatives and rare disease medicines employing more than 4,800 people worldwide. As a joint company, we function as a bridge between donors and the people who need treatment, and work on a global scale to expand patient access to plasma-derived therapies. </p><p>Please apply today for immediate consideration.</p> •
Last updated on Feb 18, 2025