1 to 25 of 42 CAPA Jobs in the UK

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 »

experience. 2 years’ experience working in a Quality Assurance role. Experience of with assessing telephone calls in a call center is preferred. Deviations and CAPA handling experience. Quality or Six Sigma Certifications are an advantage. Work in a professional manner with clients, team members and management. Analytical skills to gather 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 »

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 »

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 »

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 »

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 »

SAP, Quality Systems and H&S reporting tools. Proficient in the use of Root Cause Analysis Tools. Actively supports Non Conformance investigations and resultant CAPA(s). Coaches IFM Operations, Engineering, Technicians, Cleaning and other staff in ensuring QHSE requirements are met. Reports all non conformances to Senior Management to … and experience of QHSE continuous improvement Experience of Management and/or Supervision of staff Knowledge and experience of non compliance investigations, RCAs & respective CAPA plans Excellent Report/presentation writing skills Strong interpersonal and analytical skills Knowledge of cGMP regulations- desirable Experience of working in the Pharmaceutical or other more »

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 »

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 »

a high-performing technical operations and MSAT teams. Take a active role in the evaluation of deviations, root-cause-analysis, corrective action preventive action (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 and 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 »

Control (QC) review. Construction and submission of result tables/reports. Manage quality investigations and/or issue resolution; Corrective Action/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 »

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 »

Engineering phase of a project within the orthopaedic field where the manufacturing process is characterised by high process complexity, risk, and innovation; this includes CAPA projects as well as NPI projects. Drive innovation under initiative within the orthopaedics field's constraints. Identify new technologies which can bring innovation to support … the Supplier Quality Team Promote the sharing of knowledge about process engineering applied to orthopaedic technologies. Support the company's Corrective and preventive Actions (CAPA) activities and act as a subject matter expert for the Process Engineering tasks within the assigned CAPA project and ensure that process and timeline requirements … for CAPA are met by Corin’s Standard Operating Procedures (SOP’s) and in support of Corin’s Global Objectives. Support for internal audits. more »

Job Title: Senior Quality Evaluator - English plus ( either French, Spanish or German - B2 ) Belfast Onsite Job Description: The role of Senior Quality Evaluator is to coach team members while enforcing policies and driving quality performance, while balancing the need for more »

expectations. Daily interaction with VWR who manage site consumables and reagents via in-plant personnel. Responsibilities: Work closely with the labs to lead Deviations, CAPA’s, and Change Controls through to on-time completion. Participate in lab improvement projects. To ensure appropriate standards of cGMP, Housekeeping, Health, Safety and Environment … delivery from across the Liverpool sites to the labs in a timely manner. Keep oversight of and facilitate on time completion of DR’s, CAPA’s, Change Controls and SOP Updates Monthly and annual report writing for EM, Bioburdens and Endotoxin results, including annual product review. To collate data relating … to site and organisational changes that will impact the efficient running of the laboratories. Manage the completion of DR’s, CAPA’s, Change Controls and SOP updates working closely with the QC labs. Attendance at and presentation at DRB. CAPEX project submissions and management. Invalid reporting. Maintenance of QC metrics. more »

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 »

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 »

internal/3rd party audit methods Experience of managing quality issues across a multi-site organisation Demonstrable experience in resolution of customer complaints and CAPA 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 »

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 »

a high-performing technical operations and MSAT teams. Take an active role in the evaluation of deviations, root-cause-analysis, corrective action preventive action (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 »

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 »

KPIs) as required. Analyze company data to identify potential quality issues and support initiatives for product and process improvement. Initiate Corrective and Preventive 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 »

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 »