Stevenage, Hertfordshire, South East, United Kingdom
Russell Taylor Group Ltd
tasks related to pharmaceutical products. Ensuring products are fit for purpose before release for use or commercial sale. Maintaining and improving QMS' performance by ensuring items such as deviations, CAPAand change control for which you are the owner are progressed in a compliant and timely manner and all other items are reviewed and/or approved in accordance with … hold a degree in a STEM related subject Experienced in batch review and batch release GMP QA experience is essential! Ideally in a Pharmaceutical setting or similar Experience in CAPA, deviations, change controls, internal auditing (preferred) etc Strong interpersonal skills, we are looking for Candidates who are good communicators Strong written and verbal use of English language essential due to More ❯
with regulatory requirements (21 CFR Parts 11, 211, 600, ISO 9001, ISO 13485) and provide guidance on validation issues. Your responsibilities will include participating in investigations for failures, managing CAPA, and driving continuous improvement initiatives while maintaining and updating validation procedures. You will stay informed on the latest regulatory requirements and support the IT department in Software and Hardware Validation More ❯
regulatory compliance and risk management. Lead the QMS team, focusing on investigation simplification, robust root cause analysis, and effective CAPAs. Deliver training on investigation techniques, root cause analysis, andCAPA effectiveness. Generate and maintain the site Risk Register and ensure visibility of key risks across stakeholders. Drive continuous Quality Improvement across all UK sites. Lead Quality Improvement initiatives and the … generation of key quality metrics. Facilitate and lead forums such as the Quality Review Board, CAPA team, change control team, and participate in the Quality Committee. Ensure compliance with current regulatory requirements (e.g., MHRA, HTA, FDA). Support and deputise for the Head of Quality when required. Regularly report on QMS performance and risk-based deficiencies. Ensure quality systems are More ❯
and release of IMP to clinical studies on clients' behalf. To provide support and leadership on a range of activities including but not limited to: non-conformance management, including CAPA, events, root cause analysis, continuous improvement, key supplier issues, complaint investigations etc. Take the lead on regulatory inspections and client audits, taking accountability (with the Site Leadership Team) for the … and release of IMP to clinical studies on clients' behalf. To provide support and leadership on a range of activities including but not limited to: non-conformance management, including CAPA, events, root cause analysis, continuous improvement, key supplier issues, complaint investigations etc. Take the lead on regulatory inspections and client audits, taking accountability (with the Site Leadership Team) for the More ❯
customer complaints, supplier issues, internal incidents, holds and derogations. Providing data for KPI where required Ensuring compliance to spec driving continuous improvement through root cause analysis and troubleshooting activities (CAPA) Driving cross functional communication with operations team, engineering and NPD (including other teams as relevant) to provide timely and correct information in line with job role Completing and taking part More ❯
Manchester, North West, United Kingdom Hybrid / WFH Options
Genedrive
to maintain regulatory compliance Provide QA/RA expertise throughout product development and change control processes Guide risk management and post-market surveillance activities Conduct root cause analyses for CAPA investigations Review SOPs, software development documents, and regulatory submissions Deliver training to ensure quality and regulatory understanding across the business Perform internal and supplier audits and support external inspections Validate More ❯
development of organizational strategies by aligning quality and compliance with company goals - Sign off on deliverables as per the approval matrix - Support and guide the team in ongoing development, CAPA/NC activities, training tracking, RFx responses, and continuous improvement activities - Act as the Management Representative and oversee Management Review meetings Skills - Experienced professional with a strong understanding of transforming More ❯
primary contact with regard to Quality performance Administer the Fault Analysis Reporting process and ensure that the reports are distributed to management and monitor the completion of the correctiveandpreventiveaction of each entry. Manage the internal and external audit process and assist with audits where appropriate and/or necessary. To ensure that the Quality Systems are harmonised More ❯
team ? Exceptional benefits and career development ?? Key Responsibilities: Accreditation & Compliance Maintain ISO9001, ISO13485, ISO18001, ISO14001, and ISO45001 standards Conduct internal and external audits Ensure REACH and ROHS compliance Manage CAPAand document control systems Quality Control Improve manufacturing quality controls to reduce defects and costs Manage supplier performance and customer returns Implement corrective actions to enhance customer satisfaction Customer Support More ❯
and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong More ❯
Leighton Buzzard, Bedfordshire, South East, United Kingdom
1TECH STAFFING LIMITED
and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong More ❯
tasks, and mentor junior team members. What you'll need: Experience in a Quality Assurance function in pharmaceutical or food manufacturing Experience with QA tools such as RCA andCAPA Auditing experience Ready to join a company offering the chance of genuine progression? Click apply, and let's discuss your future. By clicking Apply you accept our privacy policy (see More ❯
/efficiency and maximizing customer satisfaction with the overall goal to increase our overall efficiency and reduce our cost to provide service. You will be a key member of CAPA review board and oversee the execution/follow-up of current CAPAs assigned to Service. Responsibilities Technical Leadership & Escalation Management Lead resolution of complex technical issues escalated from global service More ❯
experience. Bachelor's degree in engineering or equivalent scientific/technical discipline. System-based thinking and excellent analytical skills are required. Expert using quality tools such as FMEA, SIPOC, CAPA, 5 Why's, 8D, RCCA, TQM. Expert knowledge of ISO 9001:2015 Quality Management System. Experience with working in a Test-Driven Development environment. Must possess an innate sense of More ❯
the implementation and maintenance of ISO9001 and other relevant quality standards Conduct internal audits and assist in customer/supplier audits Investigate quality issues, implement corrective/preventative actions (CAPA), and track non-conformances Monitor production processes and liaise with cross-functional teams to ensure compliance with quality specifications Develop and maintain quality documentation, SOPs, and inspection plans Provide support More ❯
based in Staffordshire: HNC/HND/Bachelors degree in Engineering Relevant quality assurance or engineering certification MUST have come from a production/manufacturing background Proficient in 8D, CAPA, Six Sigma, SPC This is a great opportunity for Quality Assurance Engineer (Manufacturing) that has attention to detail, takes pride in their work and wants to do the best for More ❯
Assessments to validate readiness for production transfers. 🧾 Non-Conformance & Risk Management Document audit findings, raise non-conformances, and agree on corrective/preventive actions (CAPAs). Follow up on CAPA implementation and effectiveness. Identify risks and improvement opportunities to inform supplier development strategies. Tools & Methodologies Use internal audit platforms and industry standards (e.g., AS/EN 9101, Nadcap). Apply More ❯
Cambridge, Cambridgeshire, United Kingdom Hybrid / WFH Options
Nuclera
devices such as networked laboratory instruments, IoT devices, or embedded systems Familiarity with non-functional testing areas, including performance, stress, and scalability testing Exposure to quality methodologies such as CAPA (CorrectiveandPreventive Actions), 8D Problem Solving, or Six Sigma Ability to contribute to test strategy documentation and quality-related process improvements across cross-functional teams Familiarity with software security More ❯
and maintain product specifications and process procedures, including monitoring approval records (Agility System). Control of contract quality plans and monitor live QP s for daily status. Control of CAPA s, ECR s. Certificate checks and stamped sign off against standards and HT PO text. Control of Sub- Contract deliveries monitoring progress, compliance, and due dates. Maintain and control of More ❯
levels to ensure traceability. Identify, segregate, and document non-conforming products, and support Quality and Operation teams to resolve quality issues. Assist in root cause investigations and support correctiveandpreventiveaction processes. Maintain a clean and organised inspection area maintaining appropriate H&S standards. Update the company’s ERP system with accurate and timely quality data, including inspection results More ❯
to recommend service improvements. Work with ITSM teams to ensure accurate SLA tracking and OLA performance reporting within ServiceNow. Support the definition and implementation of correctiveandpreventive actions (CAPA) based on insights. Develop and manage automated and custom reports from ServiceNow Performance Analytics, ServiceNow Reporting, and other BI platforms (e.g., Power BI) Create real-time dashboards to monitor IT More ❯
Manchester, Lancashire, United Kingdom Hybrid / WFH Options
QIAGEN Gruppe
in manufacturing/assembly/testing/service related tasks with aptitude for metrology and mechatronics; preferably working in interdisciplinary and international teams. - Knowledge of quality methods such as CAPA, cGMP, FMEA, ISO would be beneficial. - Experience with product development and/or life cycle management in a regulated environment (Design Controls according to European and U.S./FDA guidelines … in manufacturing/assembly/testing/service related tasks with aptitude for metrology and mechatronics; preferably working in interdisciplinary and international teams. - Knowledge of quality methods such as CAPA, cGMP, FMEA, ISO would be beneficial. - Experience with product development and/or life cycle management in a regulated environment (Design Controls according to European and U.S./FDA guidelines More ❯