1 to 25 of 98 21 CFR Part 11 Jobs in England

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 Hands-on SAP functional 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 Hands-on SAP functional 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 ❯

Responsibilities Oversight and Compliance : IT CSV oversight for GXP computerized systems. Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5). Handling deviations, CAPAs, and change controls. Documentation and Review : Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, traceability … Computer Science, Chemistry, or a relevant scientific field with substantial relevant progressive experience (greater than 3 years). Extensive experience in regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, and EU Annex 11 compliance requirements. GLP/GCP/GMP experience is preferable. Experience in supporting regulatory inspections. #J More ❯

independently whilst establishing a high-trust environment with the client’s counterparts. Main Job Tasks and Responsibilities: Implement software systems in conformance with regulatory requirements as they pertain to CFR 21 Part 11. Ensure compliance with corporate initiatives and company standards. Develop and maintain a comprehensive IT Quality Assurance Program in support of the company's pipeline. … applications. Assist to create test transactions and run tests to find errors and confirm programs meet specifications. Consult with suppliers to prototype, refine, test, and debug programs to attain CFR 21 Part 11 compliance/approval. Write and maintain documentation to describe program development, logic, coding, testing, changes, and corrections. Provide technical assistance by responding to … information is missing, convoluted, and/or unclear. Effective verbal and written communication skills. Ability to clearly document and report testing-effort results. Ability to work independently or as part of a team in the resolution of problems and completion. Knowledge of IT QA procedures and processes including acceptance testing procedures, defect tracking, benchmarking, process simplification and effectiveness improvement More ❯

PoE, AV-over-IP, BICSI, ITIL, and network architecture. Experience working with project delivery models (e.g., EPCM, Design-Build, IPD). Knowledge of relevant regulatory and cybersecurity frameworks (e.g., 21 CFR Part 11, ISO/IEC 27001). Excellent stakeholder management, communication, and organizational skills. Fluent in English; additional languages (German, French, etc.) are an asset … on pharmaceutical campuses, labs, or manufacturing facilities. What We Offer: Competitive compensation and performance-based bonuses. Work with leading-edge technologies in a purpose-driven organisation. Opportunity to be part of global flagship facility projects. Strong focus on professional development, health & wellness, and diversity & inclusion. More ❯

PoE, AV-over-IP, BICSI, ITIL, and network architecture. Experience working with project delivery models (e.g., EPCM, Design-Build, IPD). Knowledge of relevant regulatory and cybersecurity frameworks (e.g., 21 CFR Part 11, ISO/IEC 27001). Excellent stakeholder management, communication, and organizational skills. Fluent in English; additional languages (German, French, etc.) are an asset … on pharmaceutical campuses, labs, or manufacturing facilities. What We Offer: Competitive compensation and performance-based bonuses. Work with leading-edge technologies in a purpose-driven organisation. Opportunity to be part of global flagship facility projects. Strong focus on professional development, health & wellness, and diversity & inclusion. More ❯

no-code tools is advantageous but not essential. Proven track record of leading MES projects from start to finish. Understanding of Pharma/Biotech processes and regulations (GMP, FDA 21 CFR Part 11, GAMP5). Strong problem-solving and communication skills. Willingness to travel to client sites. What We Offer: Competitive salary and benefits. Growth and More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

compliant computer systems, and acts as an information resource for the delivery teams and wider business. Skills & Experience Strong understanding of GXP Regulations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.) Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products. Detailed understanding of computer system validation and infrastructure … years experience with CSV, process validation, QA or compliance functions in pharmaceutical or Medical Device industry. Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11, etc. Excellent presentation and writing skills. Travel Requirements Up to 10% travel within Europe (may require overnight stays). Working Conditions Hybrid More ❯

compliant computer systems, and acts as an information resource for the delivery teams and wider business. Skills & Experience Strong understanding of GXP Regulations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.) Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products. Detailed understanding of computer system validation and infrastructure … years experience with CSV, process validation, QA or compliance functions in pharmaceutical or Medical Device industry. Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11, etc. Excellent presentation and writing skills. Travel Requirements Up to 10% travel within Europe (may require overnight stays). Working Conditions Hybrid More ❯

understanding of FDA and ICH/GCP regulations and guidelines related to data capture and data management processes; strong familiarity with CDISC standards (CDASH/SDTM), medical dictionary coding, 21 CFR Part 11, and industry best practices Exceptional interpersonal, communication, and organizational skills, with the ability to oversee multiple programs and workflows in a dynamic, team More ❯

maintain control systems using PLC, DCS, HMI, and SCADA technologies. Write and review key documentation (URS, SDS, IQ/OQ/PQ, SOPs) and ensure compliance with GAMP and 21 CFR Part 11. Support system lifecycle activities, including change control and system upgrades. Troubleshoot control systems and instrumentation, perform root cause analyses, and recommend improvements. Lead the … commissioning, and validation. Soft Skills: Strong leadership, communication, and technical writing skills. Comfortable working in cross-functional teams and adapting standard principles to complex challenges. Why Join Us? Be part of a pioneering R&D setup with direct influence on design and operations. Thrive in a dynamic, innovation-driven environment with clear opportunities for progression. Enjoy a competitive salary More ❯

maintain control systems using PLC, DCS, HMI, and SCADA technologies. Write and review key documentation (URS, SDS, IQ/OQ/PQ, SOPs) and ensure compliance with GAMP and 21 CFR Part 11. Support system lifecycle activities, including change control and system upgrades. Troubleshoot control systems and instrumentation, perform root cause analyses, and recommend improvements. Lead the … commissioning, and validation. Soft Skills: Strong leadership, communication, and technical writing skills. Comfortable working in cross-functional teams and adapting standard principles to complex challenges. Why Join Us? Be part of a pioneering R&D setup with direct influence on design and operations. Thrive in a dynamic, innovation-driven environment with clear opportunities for progression. Enjoy a competitive salary More ❯

Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca's Alexion division, you'll find … ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide More ❯

wide range of different types of systems used within the life sciences including MES, QMS, ERP, LIMs, SAS, SAP, etc. - A knowledge and understanding of the requirements related to 21 CFR Part 11, EU Annexe 11, Data Integrity, and GAMP. - Experience in handling regulatory inspections and audits is an advantage. - Computer literacy, including proficiency with More ❯

years delivering MES solutions (Tulip or similar platforms - e.g. Siemens, Rockwell, Koerber, etc.) Strong experience in integration: ERP, lab systems, IoT, machines A practical grasp of GMP, GAMP5, and 21 CFR Part 11 Familiarity with business process mapping from URS to validation Confident working across Fit-Gap, presales, and improvement phases Curious, modern mindset — excited by More ❯

industry Minimum of 2 years of experience in Risk Based Quality Management Robust understanding of the drug development process and clinical trial execution Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP) Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well More ❯

expertise in software development and project management. Proficiency in both Agile/SCRUM and Waterfall methodologies is essential, as well as comprehensive understanding of regulatory frameworks such as FDA 21 CFR Part 11. The ideal candidate will be a confident leader and team motivator, capable of combining strategic thinking with strong communication, interpersonal, and customer service skills. … submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation. Seniority level Seniority level Director Employment type Employment type Part-time Job function Job function Management Industries Strategic Management Services Referrals increase your chances of interviewing at Studio di Architettura Andrea Della Sala by 2x Sign in to set More ❯

expertise in software development and project management. Proficiency in both Agile/SCRUM and Waterfall methodologies is essential, as well as comprehensive understanding of regulatory frameworks such as FDA 21 CFR Part 11. The ideal candidate will be a confident leader and team motivator, capable of combining strategic thinking with strong communication, interpersonal, and customer service skills. More ❯

expertise in software development and project management. Proficiency in both Agile/SCRUM and Waterfall methodologies is essential, as well as comprehensive understanding of regulatory frameworks such as FDA 21 CFR Part 11. The ideal candidate will be a confident leader and team motivator, capable of combining strategic thinking with strong communication, interpersonal, and customer service skills. More ❯

STAT. Knowledge of SAS/Graph, and SAS/SQL. Knowledge and implementation of: SDTM and ADaM principles. Relational Databases. Good Clinical Practice principles. Good Programming Practice principles. 21CFR Part 11 Standards principles. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. When we put unexpected teams in the More ❯

startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Responsible for industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. Development of detailed specification, engineering documents, SOP and operating standards. Ownership and administration of process control automation in a GMP regulated … and Personal Experience: B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering. Experience working with Emerson DeltaV DCS systems version 11 or above, Rockwell Automation Factory Talk & ControlLogix PLC Platform. Working knowledge of building automation systems, electronic batch records, PLC, OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies, as well as 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 ❯

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 ❯