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 ❯
the R&D team and senior management. Maintain current knowledge of federal, state, and international regulations and guidance documents, as applicable (QSR, cGMP, ISO, ICH, etc.). Support NCMR, CAPA, Complaint, and Internal Audit investigations as needed. Thoroughly document all issues related to quality control, QSR, cGMP, ICH, and ISO compliance. Support company goals and objectives, policies, and procedures. Requirements 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 ❯
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 ❯
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 ❯
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 ❯
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 ❯
/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 ❯
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 ❯
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 ❯
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 ❯
Provide technical support for customer and product investigations, defect resolution, lifecycle maintenance, and feature enhancements. Process and Documentation: Contribute to software process controls, design documentation, risk management activities, andCAPA processes. Requirements and Architecture: Translate customer and business requirements into robust embedded systems and software architectures aligned with product goals. Technical Analysis: Interpret technical documentation such as circuit diagrams andMore ❯
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 ❯
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 ❯
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 ❯
Engineer include: Collaborate with the production team to ensure the conformance of goods and sample inspection of manufactured products. Lead problem-solving efforts to identify root causes and complete CAPA (CorrectiveandPreventive Actions). Manage customer returns processes, including root cause analysis andcorrective actions, ensuring timely resolution of customer issues. Evaluate processes and make continuous improvements, implementing new More ❯
Basingstoke, Hampshire, South East, United Kingdom
Orion Electrotech Manufacturing
Engineer include: Collaborate with the production team to ensure the conformance of goods and sample inspection of manufactured products. Lead problem-solving efforts to identify root causes and complete CAPA (CorrectiveandPreventive Actions). Manage customer returns processes, including root cause analysis andcorrective actions, ensuring timely resolution of customer issues. Evaluate processes and make continuous improvements, implementing new 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 ❯
High Wycombe, Buckinghamshire, England, United Kingdom
Cpl Life Sciences
research into new materials and capabilities for future product developments Diagnose product complaints received, identifying the root causes of any problems. Systematically capture all analysis and resultant actions in CAPA system. Write and manage all inputs and analyses required for the Company’s technical files, working closely with the Company’s regulatory consultant. Work with Manufacturing to identify and evaluate 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 ❯