Caernarfon, Gwynedd, Wales, United Kingdom Hybrid / WFH Options
Siemens Healthineers
regulatory requirements, and ensure business needs are met through the delivery and operation of vigilance and post market activities, internal and external audits andCAPA System. This is a home-based role (#LI-REMOTE) with occasional travel to our site in Llanberis. Your Role: You will provide support for post … market activities and representation on various product related meetings. You will be responsible for the effectiveness of CAPA, internal/external audits, input to Management Review at site level. You will support corporate QM function with site vigilance activities. You will support the site with internal and external investigations/ more »
Cardiff, South Glamorgan, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: CorrectiveandPreventiveAction (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance andmore »
and implement continuous improvement activities across all areas related to countries and regions PV activities to optimise quality and productivity, including process improvement andCAPA management and implementation Work closely with Global Process Owners to ensure local implementation of global pharmacovigilance procedures For assigned countries, primary GPV point of contact … develop holistic understanding of situations and requirements, in order to deliver solutions that work across stakeholders Strong collaborator and problem solver Quality mindset inc CAPA management Fluent in English Computer literate Additional Information Personal Attributes Required: Strong communication skills, including across geographies and functions Strong analytical/problem-solving skills more »
Teams & email communications regarding product quality Telephone, MS Teams & email communications regarding ongoing product/process improvement activities Telephone, MS Teams & email communications regarding CAPA activities Other Telephone, MS Teams & email communications as deemed required by the Quality Manager at the Dundee site Draft/update/improve supplier quality … well as NCMR/CARs assigned by or to other Smiths Interconnect sites. SUPPLIER Quality & Development – Partner with supply chain in adequate completion of CAPA requests due to nonconforming or discrepant material. Collaborate with regularity ensuring supply chain partner are engaged in continual improvement activities. MRB ACTIVITIES - Coordination of MRB more »
the team to maximise output and continuous improvement using effective resource management. You will be leading continuous improvement projects, including but not limited to CAPA, process control and EHS action closure. You will be responsible for your teams development, reward, feedback, adherence to process and effective management through HR Policies. … Experience of Lean implementation Results driven, and flexible to customer demands. Experience of leading continuous improvement projects Knowledge and experience of Quality System activities - CAPA, Non-conformance, QN process Our Benefits: 26 days' holiday with the option to buy or sell an additional 5 Up to 10% employer pension contribution 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 andmore »
MHRA requirements. Manage the investigation of laboratory related transfusion incidents & errors. This also involves the reporting to MHRA, SHOT & DATIX as well as setting CAPAand 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 »
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 »
system (Agile); including but not limited to Policies, Manuals, Standard Operating Procedures, Training Instructions and Batch Records. This includes document review and approval. Perform CAPA Coordinator activities; coordination Quality Incidents and Deviations within a Quality Management System (Agile. Proactively contributing to continuous improvement initiatives and other general housekeeping duties. Taking … Design and Manufacture of In-vitro Diagnostics Experience with an Enterprise Resource Planning System (ERP) Experience with Electronic Document Management Systems (EDMS) Experience with CAPA systems - Agile preferred Proficient with MS Word, Excel and Power-Point Join our team and contribute to a dynamic environment where your skills will be 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 »
Cheshire, Chester, North West Hybrid / WFH Options
Real Staffing
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 andmore »
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 »
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 »