1 to 25 of 33 Permanent CAPA Jobs in England

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 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 »

Participate in the review and approval of GMP documentation, including batch records, SOPs, and change controls. Assist in deviation investigations, root cause analysis, and CAPA activities to address quality issues. Aid in handling customer complaints, conducting investigations, and implementing preventive measures. Support in preparing for regulatory inspections and customer audits. 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 »

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 »

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 »

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 »

relevant to outsourced activities. Support inspection preparation and facilitation in collaboration with other QA groups. Manage follow-up activities for audits and inspections, including CAPA preparation. Lead a team to ensure a unified approach to proactive support for clinical trials. Key Skills and Requirements: Experience in a GCP Environment within more »

departments to provide Quality Assurance support. • Participation in external Quality audit activities. • Representing QA for various projects across the Basingstoke sites. • Key QMS processes – CAPA, Complaints, R&D QA, internal audits • Developing processes and providing training to R&D teams. What can we offer you? As Quality Assurance Engineer, you more »

KPI’s & support of the Quality strategy To ensure all procedures within the Quality Management System are being used correctly, amongst others this includes CAPA, Non-conformance & ECN (where possible this is to be done by providing guidance and offering training) Adhere and respect the company’s Health and Safety 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 »

in the event of a quality concern or non-conformance and implementation of corrective actions. * Utilise, when required the following quality tools/processes – CAPA, 5 Why’s, FMEA, PFMEA, 8D, Control plans, SPC, PPAP. Health & Safety: * Drive improvements to the H&S culture in the business by actively reporting 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 »

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 »

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 »

the date base for SOP. Provide training on SOPs to staff members. Work with HR to create SOP training plan. Handle complaints, returns recalls, CAPA and investigations. Retrieve reports from Navision, as required to support QA/QC investigation of Customer complaints or Product Recalls. Prepare Risk assessments. Conduct change … control evaluation. Conduct Self - inspection and provide Self-inspection report/Self inspection CAPA reports. Inform appropriate internal departments on audit results and work with the necessary staff to achieve GMP &GDP compliance. Ensure the implementation of corrective actions that are raised by deviations, internal audit, or regulatory inspection. Provide … regulatory assurance Proven experience in Quality Management Systems (QMS) and ensuring continuous improvement Experience with some or all of the following: Deviations/Investigations CAPA, complaints and recalls Risk management plan Experience in performing internal audits Experience working with pharmaceutical supply chain Experience in supplier/customer qualification, transport company more »

Compliance and Quality Assurance Manager Our trailblazing global AAC (Augmentative and Alternative Communication) company, is on the lookout for an exceptional Compliance and Quality Assurance Manager to join our product development team and report to the Head of Hardware. At more »

and Regulatory requirements and to ensure that proprietary information is protected at all times. Responsible for the recording and investigation of Non conformances and CAPA using root cause analysis tools where appropriate and regular reporting on NCs and CAPAs. Responsible for NC and CAPA process management and regular reporting of … RA Manager & RP in ensuring that a quality management system (QMS) is implemented and maintained including quality risk management, documentation management, non-conformance and CAPA, change management, deviation processes, internal and supplier approval and audits as well as measurement of performance indicators and management review Take ownership for assigned projects more »

tool for improvement as well as compliance and challenges existing practice where appropriate. Supports and process NC and/or Corrective and Preventive Action (CAPA) to address operational issues within the PPA areas. Supports with project related document and technical review. Generation and monitoring of data streams and analysis to … functional teams whilst ensuring that deadlines are met. Competent auditor. Experience in hosting or acting as SME during external regulatory audits. Strong knowledge and experience of CAPA and NC for medical devices A practical working knowledge of implementation of change control, and of all aspects of the process and equipment more »

EMEA QSHE Lead - UK OR Europe, REMOTE - to £85k plus car allowance, bonus and benefits. A superb opportunity to join one of the best Facility Management companies in Europe. This is a replacement role for someone who has been promoted more »