1 to 25 of 41 Permanent CAPA Jobs

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 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 »

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 »

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 »

customer, regulatory, internal & compliance audits. Analysis of quality data & generation of quality reports. Support final product disposition & control of non-conforming material. Support the CAPA process, including deviations & customer compliant investigations, ensuring robust root cause analysis & appropriate corrective actions are implemented. Coaching and training of production and technical personnel on 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 »

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 »

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 »

findings, and support supplier audits. Update Quality reports and KPIs. Analyze data for quality issues and support improvement initiatives. Initiate Corrective and Preventive 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 »

continuous improvement for both products and processes and to support new product/process development activities. These activities include, process validation, defect analysis, corrective and preventive action, problem solving activities related to products and processes, performing internal audits to verify compliance with ISO and FDA Regulations, supporting external audits, and 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, management and post audit follow up of customer audits and regulatory more »

requirements. Work Closely with Mixing and Production in the development of IPC's for new products. Support all site functions with technical investigations and CAPA actions linked to process/formulation non-conformances. Required Experience Qualified to at least BSc or equivalent in Chemistry or a similar technical discipline Good 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 »

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 »

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 »

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 »

implementation of appropriate countermeasure actions. * Lead and support structured problem solving teams to bring customer, internal & supplier quality issues to conclusion. * Compilation of quality CAPA (8D) reports on non-conforming products or information received from customer complaints/warranty product reviews, internal quality and supplier quality concerns. * Maintenance of all more »

radioactive contamination. Carry out regular stock checks of Radiopharmacy consumables. When stock is delivered check for completeness and put away the delivery appropriately. Completing CAPA report forms as required. Carry out and record daily contamination surveys and monitor waste during storage until disposal to comply with IRR 17 and EPR 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 »

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 »

appropriate problem-solving tools. Conduct drawing and specification reviews as part of feasibility studies. Drive quality improvement throughout the business, using 5 Why, FMEA, CAPA and 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 »

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 »

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 »

processes 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, required more »