16 of 16 21 CFR Part 11 Jobs in the UK

about Convatec, please visit Change is everywhere at Convatec. It's transforming our business, and helping us improve millions of lives. And we're nowhere near finished. Across every part of our business, we're pushing for better. Join us on our journey to as a System Owner/Technical Lead LIMS, and you'll do the same. Position … efficient, and well-documented LIMS configurations and scripts, following best practices and compliance standards. Participate in system reviews and validation activities to ensure system quality, regulatory compliance (e.g., GxP , 21 CFR Part 11), and data integrity. Troubleshoot, debug, and upgrade existing LIMS systems to ensure optimal laboratory operations and minimal downtime. Contribute to the full system … systems. Proficient in system configuration, scripting, and integration with laboratory instruments and enterprise systems (e.g., ERP). Strong understanding of laboratory processes, data management, and regulatory requirements (e.g., GxP , 21 CFR Part 11). Experience with software development methodologies (e.g., Agile, Scrum) and system validation practices. Familiarity with database technologies (e.g., SQL) and web services (e.g. More ❯

software products. You'll be responsible for aligning information security and data protection with our mission to deliver FDA-regulated digital therapeutics. This includes leading regulatory security compliance (HIPAA, 21 CFR Part 11, FDA SaMD guidelines), proactively managing risk, and collaborating across engineering, product, compliance, and leadership teams. Location NYC, London, Ramat-Gan This role is … the opportunity to collaborate closely with our dynamic team in person. Responsibilities Design, implement, and lead Remepy's security practice and enterprise cybersecurity program Own security compliance with HIPAA, 21 CFR Part 11, FDA pre/postmarket cybersecurity guidance, and related frameworks Collaborate with Product, Engineering, and Compliance to embed security-by-design across our software More ❯

PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail … to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of … skills, and geographic location. The anticipated wage for this position is $63,750 - $180,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation More ❯

decision making in life sciences quality and compliance. The company's solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001. Who we're looking for We are looking for Salesforce Implementation … to become an integral part of our Professional Services team at Dot Compliance. At Dot Compliance, we strive to ensure customers' satisfaction and an effective onboarding process. As a Salesforce Implementation Specialist, you will work closely with the professional services global team to support technical activities during customer onboarding stage, develop custom solutions, tools and scripts to improve the … platform, allows life science customers to manage their quality and compliance Our ideal candidate should be passionate about learning new technologies, organizing information data, and keen on becoming a part of a growing and dynamic team. You will succeed in this role if you are a problem solver who likes to work with data and people to drive the More ❯

of successfully selling and overseeing complex and small-scale projects alike. Experience in technology implementation and migration projects within the life sciences industry (regulatory, quality, clinical) with regulated software (21 CFR Part 11, EU Annex 11). Proficiency in CRM solutions (e.g., Dynamics 365, Salesforce). Knowledge of project management methodologies (e.g., Agile, Waterfall) and More ❯

decision making in life sciences quality and compliance. The company's solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001. Who we're looking for Dot Compliance is a leading provider … biotech and medical device companies manage their quality and compliance regulated processes. We are looking for an English and German speaking Customer Success Manger (CSM) to become an integral part of our Customer Success team. As a CSM, you will lead the customer through their journey at Dot Compliance, facilitate adoption and ensure engagement. You will be working in More ❯

PLC systems within a pharmaceutical manufacturing site. Develop and implement validation documentation including URS, IQ, OQ, PQ, and validation plans. Ensure compliance with regulatory requirements (e.g. GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11). Perform risk assessments, impact assessments, and deviation investigations. Collaborate with cross-functional teams including automation, quality, and More ❯

systems like LIMS, SCADA/HMI, and PLC-integrated devices. Collaborate with infrastructure teams and vendors to resolve escalated issues. Ensure compliance with Computer System Validation (CSV), GxP, and 21 CFR Part 11 standards. Document support activities accurately using the IT helpdesk system. Deliver technical onboarding and system usage training to end users. Proactively recommend improvements More ❯

systems, HMI packages, building management systems, SCADA systems, and PC networking technology Familiarity with FDA GMPs and FDA regulations relating to biologic and drug products Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11 More ❯

external vendors Support installation/configuration of validated and non-validated systems Assist in patching, updates, and system maintenance Ensure adherence to validation standards such as CSV, GxP, and 21 CFR Part 11 Maintain accurate support records via the helpdesk system Provide onboarding and training to end users Identify and propose improvements in IT services and More ❯

Partner to implement and troubleshoot end-to-end solutions, supporting a robust and scalable environment. Compliance and Regulatory Adherence: Ensure all processes adhere to industry standards, GxP regulations, FDA 21 CFR Part 11, and internal governance frameworks. Monitor system performance and integration functionalities to support audit readiness and risk mitigation. Qualifications & Experience Experience: At least 10+ More ❯

technical training will be provided. Proven experience in leading complex MES projects from concept to deployment. Knowledge and understanding of Pharma and Biotech industry & processes. Familiarity with GMP, FDA 21 CFR Part 11, GAMP5, and other relevant regulatory requirements. Excellent problem-solving, communication, and interpersonal skills. Ability to travel as required to client sites. What We More ❯

pharmaceutical operations, including inspection planning, in-process and final inspections, batch management, quality notifications, results recording, and certificates of analysis . Ensure compliance with Good Manufacturing Practices (GMP) , FDA 21 CFR Part 11 , and other relevant pharma regulations. Integrate QM with MM, PP, PM, and EWM in an S/4HANA environment to support end-to More ❯

preferred) 3+ years of experience in product management within healthcare or life sciences Proven expertise in product lifecycle management and regulatory compliance (e.g., FDA 510(k), CE marking, GCP, 21 CFR Part 11) Strong proficiency in translating business needs into technical requirements and collaborating on UX/UI workflows Demonstrated ability to lead cross-functional teams More ❯

driving secure, scalable DevOps practices across the organization. This includes building and automating infrastructure, championing compliance-ready CI/CD pipelines, and aligning system architecture with regulatory requirements (HIPAA, 21 CFR Part 11, FDA SaMD guidelines). You will work cross-functionally with engineering, product, compliance, and leadership teams to deliver infrastructure that meets the highest More ❯

driving secure, scalable DevOps practices across the organization. This includes building and automating infrastructure, championing compliance-ready CI/CD pipelines, and aligning system architecture with regulatory requirements (HIPAA, 21 CFR Part 11, FDA SaMD guidelines). You will work cross-functionally with engineering, product, compliance, and leadership teams to deliver infrastructure that meets the highest More ❯