76 to 99 of 99 21 CFR Part 11 Jobs in England

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 ❯

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 ❯

Quality Engineering, Quality Assurance or Regulatory role with medical devices. Knowledge and experience in medical device Quality Management Systems and regulatory processes including ISO 13485, ISO 14971, ISO 27001, 21 CFR Part 11, 21 CFR Part 820, MDR 2017/745, IEC 62304. Proven track record in interactions with Notified Bodies and/ More ❯

escalated technical issues when necessary. Monitor system performance and suggest improvements to enhance efficiency. You can bring your whole self to work. At Capgemini equity, diversity and inclusion is part of everyday life, and will be part of your working reality. We have built an inclusive and welcoming environment, for everyone. We have a number of networks you … procedures within lab systems. Excellent communication skills, both written and verbal, with the ability to communicate technical concepts to non-technical stakeholders. Ability to work both independently and as part of a collaborative team. Strong problem-solving and analytical skills. Preferred Qualifications: Experience with other lab systems or data management tools. Knowledge of laboratory automation or process control systems. … Familiarity with compliance standards such as GxP, 21 CFR Part 11, and ISO regulations. Don’t meet every single requirement? Studies have shown women and people of colour are less likely to apply to jobs unless they meet every single qualification. We are dedicated to building a diverse, inclusive and authentic workplace so if you’re More ❯

building automated quality checks, validation frameworks, or similar systems. Nice-to-haves Knowledge of relevant standards and compliance frameworks (e.g. ISO 27001, SOC 2, ISO 9001, GAMP 5, FDA 21 CFR Part 11, ALCOA+, BS 10008). Experience with regulated environments (GMP, HIPAA, etc.). Understanding of hardware-software integration. Experience with containerisation and orchestration (Docker … options - Lunch covered daily in-office with team - Collaborative team environment with very high potential to learn new skills - 32 days holiday (bank holidays, end-of-year closure, and 21 days discretionary PTO) - Pension - Awesome colleagues and an office in the Imperial College Innovation hub in White City, where you'll be based We're building a team that 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 ❯

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 ❯

and standards for all applicable markets, including but not limited to: Hazardous Chemicals: UK & EU REACH, RoHS, California Proposition 65, AB1200 Food Contact Materials: EU 10/2011, FDA 21 CFR 175-178 Electrical & Electronic Products: Low Voltage Directive (2014/35/EU), EMC Directive (2014/30/EU), Battery Directive (2006/66/EC More ❯