1 to 25 of 39 CAPA Jobs in the UK

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 »

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 »

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 »

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 »

one of the following regulated industries: ISO 9001, AS 9100, ISO 13485, IATF 16949. Experience in problem solving and investigation tools such as 8D, CAPA, 5-Whys. Experience in quality systems auditing. Experience in inspection, including first article inspection. Experience in planning and conducting supplier audits. The Package: Up to more »

to address constraints. Lead the execution of common IT processes across Data Platforms solutions and services. (ie. Access Roster Reviews, Periodic Reviews and other CAPA activities.) Represent the team in vendor governance meetings and ensure compliance with change management and ITSM processes. Minimum Qualification (education, experience and/or training more »

in reporting and assessing the suitability of our data to support verification and validation of the product's requirements. Operating under change management and CAPA systems when in appropriate stages of development. Work in accordance with 21 CFR part 820, ISO 13485, ISO 14971, IVDR, and other applicable regulations. Knowledge 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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

and Pharmacovigilance · Experience in Monitoring, Quality Assurance and/or Good Clinical Practices · Exposure to inspections COMPETENCIES · Understanding of pharmacovigilance · Understanding of audits and CAPA management · Understanding of change management processes · Well versed with MS Office (advance users in Excel & PowerPoint preferred) · Excellent communication skills (written and oral) in English more »

process, facility, SOP, CSV, and study audits. Review and maintain the BioA Central Events log, ensuring timely completion of proposed corrective and preventative actions (CAPA) by management. Act as Deputy Archivist, responsible for maintaining the archive and its contents in compliance with relevant regulations. Introduce systems to comply with revised more »

a similar role within the Medical Device/Pharmaceutical industry · (Desirable) Working knowledge and experience with a Quality Management System, such as deviations, investigations, CAPA, and customer complaints. · (Desirable) Experience of ISO certified QMS (ISO13485) Knowledge (Essential) In depth understanding of approaches to quality for legal manufactures · (Desirable) Knowledge of more »

Provide regular status update reports on Project quality goals, leading/lagging quality indicators and non-conformance management. Drive quality improvement through robust corrective and preventive action and project/activity lessons learnt through recognised tools/techniques including Cost of Quality setting, implementing, and monitoring Improvement KPIs across the 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 »

supplier audits; Support continuous improvement projects; Monitor customer and supplier rejects and highlight trends whilst implementing preventative and corrective actions to prevent reoccurrences; Complete CAPA, 8D or SCAR paperwork for customer returns Issue and update regulatory declarations (REACH, TOHS, TSCA etc); Complete supplier questionnaires for customers; Issue quarterly board updates more »

the audit schedule, including coordinating and performing audits for studies, systems and vendors as Lead Auditor. Timely distribution of audit reports, evaluation of Corrective and Preventive Action and maintaining the audit schedule in the eQMS, adapting priorities and documenting changes or updates as needed. To ensure review of Computer System more »