1 to 25 of 43 CAPA Jobs

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 »

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 »

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 »

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 »

that Data Management (DM) procedures and processes are adhered to by vendor staff through oversight of quality, cycle times, metrics and use the Issue CAPA process. Key responsibilities include, but not limited to: Project level coordination of and day to day oversight of DM tasks including: Review all DM documents 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 »

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 »

Supplier Survey Audits Document Control Inspection Records Controlled Change Notice (CCN) Quality Plan Deviation Non-conforming Product Review (NPR) Gage Management (Calibration)System Corrective and Preventive Action (CAR/PAR) Manage and maintain Quality SharePoint site including updates for monthly, quarterly, and yearly review Responsible for implementing and enhancing standards 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 »

Senior GxP IT Compliance Specialist As the Senior GxP IT Compliance Specialist, you will lead compliance efforts for critical systems essential to GxP operations. Your role involves overseeing GxP IT systems from a quality assurance perspective, ensuring adherence to regulations 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 »

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 »

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 »

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 »

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 and post audit follow up of customer audits and regulatory inspections. 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 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 »

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 »

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 »