1 to 25 of 36 CAPA Jobs in the UK excluding London

to become part of a dedicated team. Keywords: Quality, QA, assurance, GMP, manufacturing, distribution, packaging, CDMO, pharmaceutical, batch release, systems, compliance, regulatory, specialist, investigations, CAPA, deviation, change control, operations, senior, leader, supervisor, manager, coach, mentor. more »

in CPD (continuous professional development) activities through academic or practical experience Report and investigate all incidents and adverse events entering the information in the CAPA module of Q-pulse in a timely manner, conducting Root Cause analysis and remedial action as required Demonstrate on going competency against training plans and more »

drafting of new procedures to enhance the companies QMS. · Support with assessment of deviation event investigations. · Support closure to plan of Change Controls and CAPA 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 »

audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors. Execute validation protocols and drive to completion any CAPA associated with non-conformances raised. Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed. more »

Support continuous improvement initiatives and promotes a quality mindset at all levels. Ensure compliant delivery through provision of risk-based advice and training Review CAPA Process to ensure effectiveness Support the development of a risk based audit programme Maintain network of external audit providers to support CMC, pre-clinical and more »

findings, and support supplier audits. Update Quality reports and KPIs. Analyze data for quality issues and support improvement initiatives. Initiate Corrective and Preventive 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 »

audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors. Execute validation protocols and drive to completion any CAPA associated with non-conformances raised. Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed. more »

and working to support and track actions that are to be taken. Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues. Support effective pre-audit preparation, management and post audit follow up of customer audits and regulatory 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 »

apply QC procedures to ensure their accuracy • Produce and review/approve relevant documentation such as protocols, procedures, validation/study reports, SOP’s, CAPA’s, file notes. • Provide technical advice to business development and participate in laboratory-related discussions with auditors, Sponsors and internal employees. • Perform routine maintenance/ more »

requirements. Work Closely with Mixing and Production in the development of IPC's for new products. Support all site functions with technical investigations and CAPA actions linked to process/formulation non-conformances. Required Experience Qualified to at least BSc or equivalent in Chemistry or a similar technical discipline Good more »

and working to support and track actions that are to be taken. •Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues. •Support effective pre-audit preparation and post audit follow up of customer audits and regulatory inspections. more »

effectiveness of the Full Support Healthcare QMS Maintenance and communication where required of technical documentation Investigate and report on non-conformances, customer complaints and CAPA issues within specified timeframes Validation of sterilisation and packaging processes Arrange required product testing and review test reports Validation of sterilisation and packaging processes Completing more »

departments to provide Quality Assurance support. Participation in external Quality audit activities. Representing QA for various projects across the Basingstoke sites. Key QMS processes – CAPA, Complaints, R&D QA, internal audits Developing processes and providing training to R&D teams. What can we offer you? As Quality Assurance Engineer, you 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 »

appropriate problem-solving tools. Conduct drawing and specification reviews as part of feasibility studies. Drive quality improvement throughout the business, using 5 Why, FMEA, CAPA and 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 »

MHRA requirements. Manage the investigation of laboratory related transfusion incidents & errors. This also involves the reporting to MHRA, SHOT & DATIX as well as setting CAPA and trending analysis. Assist with the management of non-compliances highlighted in audits and inspections. Prepare Quality reports for the various departmental meetings. Please refer more »

that an escape occurs, the engineer also makes sure that the proper root cause investigation is conducted and that planned, tested, and implemented corrective and preventive action is taken. Experience/Skills: Extensive knowledge and experience with statutory regulations for global market products, particularly electrical/electronic systems. Ability to more »

applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and more »

and Regulatory requirements and to ensure that proprietary information is protected at all times. Responsible for the recording and investigation of Non conformances and CAPA using root cause analysis tools where appropriate and regular reporting on NCs and CAPAs. Responsible for NC and CAPA 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 and CAPA, 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 Corrective and Preventive Action (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 CAPA and NC for medical devices A practical working knowledge of implementation of change control, and of all aspects of the process and equipment more »

Analytical Team Leader (Raw Materials) Hours : 37.5 hours per week worked over a flexible work pattern Salary : Competitive and dependent on experience and suitability Ref No : HRJOB8642 Business Unit : Pharma Services Location : Loughborough, Leicestershire Open To : Internal and external candidates more »

assess external customer complaints in the global Elanco complaint system including the evaluation of the complaint investigation for correctness and an assessment of proposed CAPA within the due time periods. • To maintain a batch record review qualification status of contract manufacturers. • To monitor and to drive EEM-EMEA CAPA system. more »

quality audits to meet ISO, UK, European and worldwide regulatory requirements. Facilitate quality improvement initiatives. Analyse data for management reviews and non-conformances. Conduct CAPA and 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 CAPA and 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 »

quality audits to meet ISO, UK, European and worldwide regulatory requirements. Facilitate quality improvement initiatives. Analyse data for management reviews and non-conformances. Conduct CAPA and 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 CAPA and 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 »