39 CAPA Jobs in the UK

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 »

GMP). • 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 supporting continuous improvement in the manufacturing and warehouse environments. As well as writing/modifying SOPs, you will be involved in deviation and CAPA process oversight and will also review site training requirements. This is a highly varied position and needs someone that can be versatile and manage competing … QC, control, analytical, chromatography, HPLC, laboratory, documentation, analyst, officer, specialist, executive, administrator, good, manufacturing, practice, GMP, GLP, audit, SOP, training, complaints, batch, review, release, CAPA, deviation, change, control more »

Provide day-to-day support and be responsible to maintain the effectiveness of the Quality Management System, including, but not limited to, Document Control, CAPA, Vigilance, Risk Management, Internal Audit, Post-Market Surveillance, Supplier Monitoring and Assessment and Product Release activities Contribute to strategic improvement projects to improve business processes … made available for sale in accordance with agreed lead-times To participate in the effective management of Customer Complaints, Regulatory Reporting, Non-Conformances and CAPA To prepare and analyse data for the purpose of Management Review To ensure that all Change Control activities are effectively controlled, and outputs are correctly more »

and manage the existing QMS and work closely on the implementation and transition to an eQMS. Alongside this you will be heavily involved in CAPA & NCR processes, SOP creation, auditing and RA support. We are looking for an experienced Quality Assurance professional with a proven background in In Vitro Diagnostics … or Medical Devices. You will have strong experience in the management and/or implementation of an ISO 13485 QMS, CAPA processes and auditing. Key Responsibilities: Develop and Maintain ISO 13485 QMS Support the implementation and transition to an eQMS Creation and implementation of SOPs CAPA Process Auditing Support RA … IVD or Medical Device Industries Proven experience in the maintenance and/or implementation of an ISO 13485 QMS Proven experience and knowledge of CAPA Process and Auditing Auditing certification is highly advantageous If you have the necessary skills and experience to be successful in this role, please get in 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 »

Reports based on Health Authority feedback. - Acts as a SME for Quality oversight in preparation and conduct of audit and inspection, including interviewee and CAPA management. - Acts as a CAPA owner for any findings from audit/inspections in Trackwise. - Support inspection readiness of Global Aggregate Report office and PV … function. - Acts as subject matter expert for audits and Health Authority inspections and in case of findings, performs root cause analysis and management of CAPA for Global Aggregate report office. - Support developing, maintaining, and overseeing the key performance indicators for vendors based on the governance documents. - Quality Review of aggregate … processes. - A comprehensive understanding of pharmacovigilance, clinical development, and post-marketing safety requirements, including the regulatory safety documents required at each stage. - Experience in CAPA management as well as writing of SOPs and maintenance of templates. - Experience in working with relevant software applications (Office, SharePoint, Databases) - Experienced in regard to more »

Change Control documentation for Quality Assurance Support the maintenance of Quality System documentation Analyse and communicate proposed, new or changing requirements Review and approve CAPA documentation Provide support to routine manufacturing activities, projects, development and training Experience required: Experience working in Quality Assurance Experience operating in ISO9001 environment Excellent working … knowledge of document management systems, change control and CAPA systems Knowledge and experience of working in an ISO13485 environment is advantageous Good team player and able to work in a fast-paced environment with minimal supervision Keywords: Quality Assurance Specialist, QA Specialist, Regulatory Specialist, Quality Assurance Manager, QA Manager, ISO9001 more »

their Improvement Culture, using your insight and analysis from performing audits as to were improvements can be implemented Play an instrumental part in their CAPA division within their Quality Team, this means that you will take the reigns on investigating non-conformances and collaborate on CAPA objectives. Working with the … client) Hands on knowledge of IS0 3485 i.e. you have worked in medical device manufacturing in a quality engineering role. Solid understanding of running CAPA driven activities, therefore you will be able to provide examples of where you have worked on CAPA driven initiatives within medical device manufacturing. Thank you more »

processes to ensure the product is compliant with regulatory requirements. Responsible for responding to customer quality requests, completion of customer quality questionnaires. Review any CAPA and non-conformances raised in the IMS and working with owners to ensure adequate root cause analysis has been conducted and any corrections or corrective … Quality Systems function within an ISO 9001 Management System, or similar Experienced internal auditor for ISO 9001 or similar Experience of investigating/reviewing CAPA and an understanding of root cause analysis tools Experienced in QA/QMS activities such as documentation control and change control processes. Experience of responding more »

Are you ready to embark on a transformative journey in the medical device industry? Join us at our Cardiff Innovation Hub as a Principal Design Engineer and become a driving force behind groundbreaking NPD projects. In this role, you'll more »

defined and applied within the business. • Coordination and leadership of reported quality/technical issues from business teams and customers, ensuring that appropriate corrective and preventive action is taken by the accountable function through use of multifunctional team activities and that the originator of the issue is informed. • To perform … To conduct investigations to assess the probable root cause of any deficiency noted during process confirmation activities, informing the accountable function, and ensuring corrective and preventive action is taken. • Compile and Present Quality overview to the leadership team within the business area Required Skillset: • Ability to interpret drawings. • Ability to more »

regulatory requirements, and ensure business needs are met through the delivery and operation of vigilance and post market activities, internal and external audits and CAPA 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 »

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 »