23 of 23 Permanent 21 CFR Part 11 Jobs in the South East

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

Rockwell Automation portfolio of products such as Studio5000 & FactoryTalk Software especially FT View SE, FT Batch). Knowledge of Batch Process Control, ISA-S88 standard programming. Knowledge of GAMP, 21 CFR Part 11, ASTM E2500, GMP, etc Knowledge of Virtualisation technology. What We Offer: Comprehensive mindfulness programs with a premium membership to Calm Volunteer Paid Time More ❯

in a highly regulated industry, within quality or software development functions, with ownership of software development quality assurance Experience working with BS EN 62304, ISO 14971, ISO 13485, FDA (21 CFR Part 820, 21 CFR Part 11), UK & EU regulations Experience in the application of risk-based methodologies in the oversight of product More ❯

correctly and align with the company EDMS whilst adhering to procedures for Document Control. Cross-check documents with pre-existing quality documents. Provide document drafting, review and approval as part of equipment and software purchase and implementation. With the help of management and quality teams link quality work instructions to pre-existing SOPs. Ensure smooth day-day administrative operations … in/with Regulatory and Validation teams and QA would be beneficial. Having drafted User Requirement Specification, Validation Plans and be aware of IQ/OQ/PQ and 21 CFR Part 11 would be advantageous. Strong IT skills and knowledge of Microsoft Office Suite, principally, Word. Excellent organisational and time-management skills. Excellent record keeping More ❯