1 to 25 of 30 CAPA Jobs in England

Engineering phase of a project within the orthopaedic field where the manufacturing process is characterised by high process complexity, risk, and innovation; this includes CAPA projects as well as NPI projects. Drive innovation under initiative within the orthopaedics field's constraints. Identify new technologies which can bring innovation to support … the Supplier Quality Team Promote the sharing of knowledge about process engineering applied to orthopaedic technologies. Support the company's Corrective and preventive Actions (CAPA) activities and act as a subject matter expert for the Process Engineering tasks within the assigned CAPA project and ensure that process and timeline requirements … for CAPA are met by Corin’s Standard Operating Procedures (SOP’s) and in support of Corin’s Global Objectives. Support for internal audits. 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 »

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 »

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 »

expectations. Daily interaction with VWR who manage site consumables and reagents via in-plant personnel. Responsibilities: Work closely with the labs to lead Deviations, CAPA’s, and Change Controls through to on-time completion. Participate in lab improvement projects. To ensure appropriate standards of cGMP, Housekeeping, Health, Safety and Environment … delivery from across the Liverpool sites to the labs in a timely manner. Keep oversight of and facilitate on time completion of DR’s, CAPA’s, Change Controls and SOP Updates Monthly and annual report writing for EM, Bioburdens and Endotoxin results, including annual product review. To collate data relating … to site and organisational changes that will impact the efficient running of the laboratories. Manage the completion of DR’s, CAPA’s, Change Controls and SOP updates working closely with the QC labs. Attendance at and presentation at DRB. CAPEX project submissions and management. Invalid reporting. Maintenance of QC metrics. 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 »

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 »

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 »

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 »

and implement continuous improvement activities across all areas related to countries and regions PV activities to optimise quality and productivity, including process improvement and CAPA management and implementation Work closely with Global Process Owners to ensure local implementation of global pharmacovigilance procedures For assigned countries, primary GPV point of contact … develop holistic understanding of situations and requirements, in order to deliver solutions that work across stakeholders Strong collaborator and problem solver Quality mindset inc CAPA management Fluent in English Computer literate Additional Information Personal Attributes Required: Strong communication skills, including across geographies and functions Strong analytical/problem-solving skills 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 »

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 »

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 »

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 »

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 »

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 »

SAP, Quality Systems and H&S reporting tools. Proficient in the use of Root Cause Analysis Tools. Actively supports Non Conformance investigations and resultant CAPA(s). Coaches IFM Operations, Engineering, Technicians, Cleaning and other staff in ensuring QHSE requirements are met. Reports all non conformances to Senior Management to … and experience of QHSE continuous improvement Experience of Management and/or Supervision of staff Knowledge and experience of non compliance investigations, RCAs & respective CAPA plans Excellent Report/presentation writing skills Strong interpersonal and analytical skills Knowledge of cGMP regulations- desirable Experience of working in the Pharmaceutical or other 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 »

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 »

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 »

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 »

Healthcare. For successful applicants, Polar Speed will process basic disclosure criminal record checks. Key responsibilities: Actively support quality processes such as non-conformance and CAPA management, change controls and risk assessments, and ensure that quality system is continuously improved with the objective of assuring GDP compliance. Oversee the warehouse and … returns and exceptions are correctly processed in a timely manner. Participate in regulatory and client audits, lead internal audits/self-inspections and prepare CAPA plans addressing any observations identified. Investigation and reporting of incidents, including deviations, non-conformances, client feedback and customer complaints, including the logging, notification, investigation, reporting more »

Demonstrated computer and IT skills including databases & pharmacy specific systems for building and managing products Desirable Demonstrated ability to manage a deviations, change control & CAPA as well as perform risk assessments & root cause analysis. Demonstrated ability to manage performance. Disclosure and Barring Service Check This post is subject to the more »