1 to 25 of 28 CAPA Jobs in the UK

Ensure effective preparation for inspections and audits. Quality Systems & Risk Management Lead and maintain the QMS, implementing improvements and supporting transformation projects. Oversee investigation, CAPA management, deviations, and risk-based decision-making. Operational Excellence Support change-control processes and ensure timely resolution of quality issues. Oversee approval and maintenance ...

checking and peer review of design deliverables. Monitor quality gates and ensure review cycles are followed. Track and close out non-conformances and maintain CAPA register. Training & Engagement Deliver internal quality briefings and support technical training. Promote a culture of quality and continuous improvement. Digital Quality Tools & Innovation Support adoption ...

career within a specialist pharmaceutical manufacturer Reference Number: BBBH26365 Keywords: Quality Assurance Officer, QA Officer, Pharmaceutical, GMP, API Manufacturing, Active Pharmaceutical Ingredient, GxP, QMS, CAPA, Deviations, Change Control, Batch Release, Validation, Quality Systems, Pharmaceutical Manufacturing, Sandwich, Kent, Canterbury, Dover, Ramsgate If you're interested in this role, click 'apply ...

cleanroom environment would be beneficial. +Strong understanding of Quality Management Systems and ISO 9001. +Familiarity with quality tools such as FMEA, Control Plans, CAPA, NCR management and 8D problem solving. +Excellent analytical, organisational and problem-solving skills with strong attention to detail. +Must have the right to work ...

. NCR & RCA Management: Investigate non-conformances using structured problem-solving methodologies such as 8D, 5 Whys, and Root Cause Analysis (RCA). CAPA Governance: Drive corrective and preventive actions to improve product quality, reduce process variation, and prevent recurrence. Compliance: Ensure full alignment with ISO 9001 requirements, customer-specific ...

and maintain manufacturing engineering standards, methods and best practices Facilitate root cause investigations and structured problem-solving using methodologies such as 8D, DMAIC and CAPA Lead and facilitate the site Continuous Improvement programme including training, coaching and project delivery Manage CAPEX budgets and departmental expenditure, including preparation of business cases ...

designated business administrators, process owners and data stewards.Monitor RIM, regulatory data quality and process performance metrics, using insights to drive risk-based improvements, CAPA effectiveness, leadership decisions and prioritisation.Sponsor continuous improvement and transformation initiatives that simplify processes, strengthen data integrity, improve automation and enable global worksharing, acting as steering leader ...

tools. Familiarity with ISO 13485, ISO 9001, or other regulated quality systems. Good working knowledge of Quality documentation, including FAIRs, CTQs, inspection reports, NCRs, CAPA and Complaints. Strong teamwork and communication skillsable to collaborate across departments. Demonstrated proactive approach to identifying issues and implementing solutions. Competent in using MS Office ...

Compliance: Embed CAP/CLIA, ISO 15189, ISO 13485, IVDR, HTA and HBS requirements in day-to-day practice, including SOP authorship, deviation/CAPA management, and audit readiness, so our lab remains inspection-ready and trusted. * Clinical Trial Testing Support: Perform and oversee prospective diagnostic testing for clinical studies ...

assurance processes in accordance with AS9100 and ISO 9001 requirements. Prepare for, coordinate, and support external certification and surveillance audits. Develop and implement corrective and preventive action plans. Maintain risk registers, incident logs, and compliance documentation. Work closely with departments across the business to embed quality and compliance into everyday ...

Quality, and external vendors Required Experience: GxP System Validation/Computer System Validation (CSV) Change Control & Patch Management Compliance & Audit Readiness System Lifecycle Management CAPA & Risk Management Vendor & Stakeholder Management Project Delivery & Coordination Desirable: GMP, GxP, FDA 21 CFR Part 11, Annex 11 Working Pattern: 2-3 days per week ...

Quality, and external vendors Required Experience: GxP System Validation/Computer System Validation (CSV) Change Control & Patch Management Compliance & Audit Readiness System Lifecycle Management CAPA & Risk Management Vendor & Stakeholder Management Project Delivery & Coordination Desirable: GMP, GxP, FDA 21 CFR Part 11, Annex 11 Working Pattern: 2-3 days per week ...

manual inspection techniques and measurement tools Familiarity with quality systems such as ISO 13485 or ISO 9001 Experience with quality documentation (FAIRs, NCRs, CAPA, etc.) Strong attention to detail and problem-solving mindset Good communication skills and team-focused approach What’s in it for you? Work in a high ...

analog circuit design, signal integrity, high-speed amplifiers, bias circuits, and current sources. Extensive experience with quality systems and tools including ISO 9001, CAPA, NCMR, SPC, FMEA, Control Plans, 8D, and statistical analysis. Proven customer and supplier quality experience across wafer fabrication, assembly, testing, and optical module manufacturing. Please contact ...

engineering, medical technology or equivalent Knowledge of ISO 13485 Quality System and FDA Quality System requirements essential Experience of Quality Tools including 8D, CAPA, 5 Why, PCDA and 5S Experience of complaint investigation and resolution Benefits – Quality Assurance Manager 25 Days + Bank Holidays Private Health Care Options Competitive pension ...

Business C ontinuityLead the Operational Resilience Framework, including Important Business Services (IBS), impact tolerances and scenario testing.Oversee business continuity, disaster recovery and crisis management capa bilities.Drive continuous improvement across resilience and operational risk ma nagement. Operations & Control E nvironmentLead core banking operations including payments, settlements, reconciliations, client onboarding, KYC operations ...

conformance reports (NCR's) and then undergoing root cause analysis (RCA's) with a view of advising and agreeing on corrective and preventative actions (CAPA's). Essential Requirements: * Previous experience as a Quality Compliance Engineer or similar * At least 3 years' experience conducting audits in a highly regulated environment ...

2016. Participate in the Management Review process; establish and report QMS performance metrics for the executive team and Board. Own document control, training records, CAPA, nonconformance, change control, internal audit and supplier audit programmes for product related certifications and regulatory bodies. Direct selection process, audit and monitoring of external suppliers … consumer-scale privacy and data flows validated under GDPR, ISO 27701 and applicable US state genomic privacy requirements. PMS, vigilance, complaint handling and CAPA systems operational at consumer scale with measurable KPIs. RA/QA function appropriately resourced and embedded in product development governance. What We Offer Competitive salary with ...

reports, data views, location hierarchy, and master data. Work closely with EHS stakeholders to translate business requirements into Intelex configurations. Experience with Incident Management, CAPA, Audits, PTW, and UK/EU EHS frameworks preferred. Desirable: JavaScript/SQL/Python, Intelex APIs, data migration, ServiceNow/ITSM, and construction/ ...

attributes (IV, colour, AA, contamination levels) Introduce statistical process control (SPC), process capability analysis and data-driven root-cause investigation Own the non-conformance, CAPA and continuous improvement systems Lead internal and external audit programmes (ISO, customer, regulatory) and keep the site audit-ready Work cross-functionally with Operations, Engineering …/1616, 10/2011, 1935/2004 or equivalent) Hands-on experience of data-driven quality management: SPC, process capability, root-cause analysis, CAPA systems and quality performance dashboards Experience managing customer audits, regulatory inspections and external certification bodies Excellent analytical skills with the ability to turn complex data ...

better outcomes, faster. Since 2014, we've worked side-by-side with clients to solve complex challenges, build high-performing teams, and create lasting capa click apply for full job details ...

control audits and recording through approved channels as required. Report all incidents and adverse events to senior staff and enter the information in the CAPA module of Q-pulse in a timely manner as directed by senior staff. Demonstrate on going competency against training plans. Person Specification Qualifications Essential Relevant ...

+ Training + Career Progression Hyde Are you a Quality Assurance Engineer or QMS Engineer with experience maintaining ISO 9001 systems and managing NCRs, CAPA and corrective actions within manufacturing? Do you want to take responsibility for quality systems and continuous improvement in a role focused on compliance, documentation and … this role, you will maintain and develop the ISO 9001 Quality Management System, manage non-conformances from initial investigation through to closure and drive CAPA activity. You will also support internal and external audits, control quality documentation and investigate customer and supplier issues. You will work closely with Production, Engineering ...

Representative and ensure ongoing regulatory compliance and audit readiness. Promote a culture of quality, risk management and continuous improvement across all business functions. Lead CAPA, internal audits, supplier quality and external audit activities. Monitor quality performance, analyse trends and implement improvement initiatives. Provide quality and regulatory support throughout product development … . Experience leading internal, external and regulatory audits. Understanding of risk management principles (ISO 14971 desirable) and regulatory compliance requirements. Proven ability to lead CAPA and root cause investigations using recognised problem-solving methodologies. Experience driving continuous improvement and implementing quality improvement initiatives. Strong leadership, communication and stakeholder management skills ...

with operational teams and a strong focus on Quality Assurance . Key Responsibilities Investigation & Documentation Write and structure deviation investigations, root cause analyses, and CAPA reports Ensure documentation is clear, factual, and compliant with quality standards Support timely closure of investigations by simplifying technical content Review documentation for accuracy, clarity … approach Ability to simplify complex technical information Strong communication and stakeholder engagement skills Desirable Experience within pharmaceutical, cosmetics, or regulated manufacturing Familiarity with deviations, CAPA, and investigation processes Experience supporting audits or inspections Knowledge of document control systems What We're Looking For Methodical, organised, and quality-driven mindset Confident ...