a high-performing technical operations and MSAT teams. Take a active role in the evaluation of deviations, root-cause-analysis, correctiveactionpreventiveaction (CAPA) and change control processes with strong focus on quality, risk mitigation and regulatory compliance. EXPERIENCE Supervising or mentoring junior staff. Detailed understanding of immunology andmore »
a high-performing technical operations and MSAT teams. Take an active role in the evaluation of deviations, root-cause-analysis, correctiveactionpreventiveaction (CAPA) and change control processes with strong focus on quality, risk mitigation and regulatory compliance. Qualifications: Detailed understanding of immunology and cell therapy. Demonstrable expertise in more »
Demonstrated computer and IT skills including databases & pharmacy specific systems for building and managing products Desirable Demonstrated ability to manage a deviations, change control & CAPA as well as perform risk assessments & root cause analysis. Demonstrated ability to manage performance. Disclosure and Barring Service Check This post is subject to the more »
drafting of new procedures to enhance the companies QMS. · Support with assessment of deviation event investigations. · Support closure to plan of Change Controls andCAPA actions. · Issue, review and approval of GMP batch manufacturing records to support certification and release. · Assist in performance of internal self-inspection audits. · Support the more »
City Of London, England, United Kingdom Hybrid / WFH Options
Proclinical Staffing
Responsibilities: Independently plan, lead, conduct and report routine and non-routine audits according to the approved schedule and timelines. Produce audit reports and approve CAPA plans within internal timelines. Update the electronic audit quality systems as per relevant timelines. Organise and manage approximately 70% audit travel per year, following company more »
Pulborough, West Sussex, South East, United Kingdom
Terry Parris Associates
findings, and support supplier audits. Update Quality reports and KPIs. Analyze data for quality issues and support improvement initiatives. Initiate CorrectiveandPreventive Actions (CAPA) and Engineering Request Notes (ERN). Participate in ISO 9001, ISO 14001, and ISO 45001 internal audits. Attend Materials Review Boards (MRB) and process MRB more »
KPIs) as required. Analyze company data to identify potential quality issues and support initiatives for product and process improvement. Initiate CorrectiveandPreventive Actions (CAPA) and Engineering Request Notes (ERN) based on thorough analysis. Conduct internal audits of ISO9001, ISO14001, and ISO45001 Management Systems, ensuring compliance and following up on more »
development and troubleshooting including reviewing protocols, study plans, SOPs or reports as required. 4. You will document and complete any quality documentation (quality issue, CAPA, deviation, change control) as appropriate and within required time frames. ROLE REQUIREMENTS: To be successful in your application to this exciting opportunity as the Study more »
least two years of experience in a Pharmaceutical Quality Management System and understand and be able to complete QMS activities including: Change control Deviations CAPA QMRs Recalls Returns Training The role involves: Review, update and maintenance of the Quality Management System. Provide support and actively participate in internal and notified more »
City Of London, England, United Kingdom Hybrid / WFH Options
Proclinical Staffing
relevant to outsourced activities. Support inspection preparation and facilitation in collaboration with other QA groups. Manage follow-up activities for audits and inspections, including CAPA preparation. Lead a team to ensure a unified approach to proactive support for clinical trials. Key Skills and Requirements: Experience in a GCP Environment within more »
radioactive contamination. Carry out regular stock checks of Radiopharmacy consumables. When stock is delivered check for completeness and put away the delivery appropriately. Completing CAPA report forms as required. Carry out and record daily contamination surveys and monitor waste during storage until disposal to comply with IRR 17 and EPR more »
Control (QC) review. Construction and submission of result tables/reports. Manage quality investigations and/or issue resolution; CorrectiveAction/Preventative Action (CAPA) system management. Ensure all data is archived in accordance with company SOPs and regulatory requirements. Responsible for financial monitoring for all assigned studies, ensuring all more »
internal/3rd party audit methods Experience of managing quality issues across a multi-site organisation Demonstrable experience in resolution of customer complaints andCAPA Experience in conducting audit and managing audit schedules (internal and third party) Demonstrable experience in writing policies and procedures and managing document control systems Experience more »
Petersfield, Hampshire, South East, United Kingdom
Sierra 57 Consult
appropriate problem-solving tools. Conduct drawing and specification reviews as part of feasibility studies. Drive quality improvement throughout the business, using 5 Why, FMEA, CAPAand Ishikawa. Creation of SOPs for process activities Gauge concept design. Support QHSE Manager with any external customer or third-party audits. Support close out more »
that an escape occurs, the engineer also makes sure that the proper root cause investigation is conducted and that planned, tested, and implemented correctiveandpreventiveaction is taken. Experience/Skills: Extensive knowledge and experience with statutory regulations for global market products, particularly electrical/electronic systems. Ability to more »
Hayes, England, United Kingdom Hybrid / WFH Options
F4P Recruitment
issues and applying the tools and methodology from your experience to identify the root cause and implement corrective actions as required (8D, 5x Why, CAPA). • Ensure that all procedures and policies are being adhered to by our service partners through a series of annual audits and related measures. • Support more »
Bristol, England, United Kingdom Hybrid / WFH Options
Smartbox Assistive Technology
Compliance and Quality Assurance Manager Our trailblazing global AAC (Augmentative and Alternative Communication) company, is on the lookout for an exceptional Compliance and Quality Assurance Manager to join our product development team and report to the Head of Hardware. At more »
Bristol, Avon, South West, United Kingdom Hybrid / WFH Options
Smartbox Assistive Technology
Compliance and Quality Assurance Manager Our trailblazing global AAC (Augmentative and Alternative Communication) company, is on the lookout for an exceptional Compliance and Quality Assurance Manager to join our product development team and report to the Head of Hardware. At more »
and Regulatory requirements and to ensure that proprietary information is protected at all times. Responsible for the recording and investigation of Non conformances andCAPA using root cause analysis tools where appropriate and regular reporting on NCs and CAPAs. Responsible for NC andCAPA process management and regular reporting of … RA Manager & RP in ensuring that a quality management system (QMS) is implemented and maintained including quality risk management, documentation management, non-conformance andCAPA, change management, deviation processes, internal and supplier approval and audits as well as measurement of performance indicators and management review Take ownership for assigned projects more »
tool for improvement as well as compliance and challenges existing practice where appropriate. Supports and process NC and/or CorrectiveandPreventiveAction (CAPA) to address operational issues within the PPA areas. Supports with project related document and technical review. Generation and monitoring of data streams and analysis to … functional teams whilst ensuring that deadlines are met. Competent auditor. Experience in hosting or acting as SME during external regulatory audits. Strong knowledge and experience of CAPAand NC for medical devices A practical working knowledge of implementation of change control, and of all aspects of the process and equipment more »
City of London, London, United Kingdom Hybrid / WFH Options
Connect With Ltd
EMEA QSHE Lead - UK OR Europe, REMOTE - to £85k plus car allowance, bonus and benefits. A superb opportunity to join one of the best Facility Management companies in Europe. This is a replacement role for someone who has been promoted more »
Clerkenwell, England, United Kingdom Hybrid / WFH Options
Connect With Limited
EMEA QSHE Lead - UK OR Europe, REMOTE - to £85k plus car allowance, bonus and benefits. A superb opportunity to join one of the best Facility Management companies in Europe. This is a replacement role for someone who has been promoted more »
Bishop's Stortford, Hertfordshire, South East, United Kingdom Hybrid / WFH Options
HR GO Recruitment - Bishop's Stortford
quality audits to meet ISO, UK, European and worldwide regulatory requirements. Facilitate quality improvement initiatives. Analyse data for management reviews and non-conformances. Conduct CAPAand non-conformance investigations. Review customer complaints and maintain incident reporting. Meet LSAS objectives and targets. Core Competencies: Experience with BS EN ISO 13485 and … manufacturing environment. Internal and external quality auditing experience to ISO 13485. Passion for quality excellence. Previous quality assurance experience, including QMS documentation. Knowledge of CAPAand root cause analysis tools. Practical problem-solving approach. Understanding of ISO 14971 quality risk management principles. Self-motivated and team-oriented. Ability to manage more »
Healthcare. For successful applicants, Polar Speed will process basic disclosure criminal record checks. Key responsibilities: Actively support quality processes such as non-conformance andCAPA management, change controls and risk assessments, and ensure that quality system is continuously improved with the objective of assuring GDP compliance. Oversee the warehouse and … returns and exceptions are correctly processed in a timely manner. Participate in regulatory and client audits, lead internal audits/self-inspections and prepare CAPA plans addressing any observations identified. Investigation and reporting of incidents, including deviations, non-conformances, client feedback and customer complaints, including the logging, notification, investigation, reporting more »