company standards in relation to GMP - right first-time execution, accurate data, timely close out of Deviation Reporting (DR’s), Correctiveand Preventative actions (CAPA), Change Control, aseptic practices and housekeeping standards. Coordinates or leads investigations in Quality and other loss control incidents in Seed Manufacturing. Ensures compliance with Seqirus 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 »
City Of London, England, United Kingdom Hybrid / WFH Options
Proclinical Staffing
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 »
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 »
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 »
drafting of new procedures to enhance the companies QMS. · Support with assessment of deviation event investigations. · Support closure to plan of Change Controls andCAPA 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 »
experience. 2 years’ experience working in a Quality Assurance role. Experience of with assessing telephone calls in a call center is preferred. Deviations andCAPA handling experience. Quality or Six Sigma Certifications are an advantage. Work in a professional manner with clients, team members and management. Analytical skills to gather more »
Hull, North Humberside, North East, United Kingdom
Umbilical Ltd
Participate in the review and approval of GMP documentation, including batch records, SOPs, and change controls. Assist in deviation investigations, root cause analysis, andCAPA 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 »
and Regulatory requirements and to ensure that proprietary information is protected at all times. Responsible for the recording and investigation of Non conformances andCAPA using root cause analysis tools where appropriate and regular reporting on NCs and CAPAs. Responsible for NC andCAPA 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 andCAPA, 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 »
with cross-functional teams to investigate and resolve process and product quality issues deploying appropriate tools to assist root cause analysis. Conduct and facilitate CAPA, NC and complaint activities. Participate in facility internal audit programme and the hosting of external audits. Work towards departmental and facility objectives. Support the supplier … eQMS. Essential Skills & Experience Relevant engineering or science degree and/or relevant experience. Strong understanding of quality assurance and manufacturing processes. Experience in CAPA, NC, complaint and change control activities. Experience in highly regulated environment (healthcare, aerospace, defence). Experience of developing and auditing quality processes, documents, plans etc. more »
tool for improvement as well as compliance and challenges existing practice where appropriate. Supports and process NC and/or CorrectiveandPreventiveAction (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 CAPAand NC for medical devices A practical working knowledge of implementation of change control, and of all aspects of the process and equipment more »
milestones and deliverables effectively and report and communicate progress to stakeholders. Report and investigate all incidents and adverse events entering the information in the CAPA module of Q-pulse in a timely manner, conducting Root Cause analysis and remedial action as required. Chair/lead and/or participate in more »
control audits and recording through approved channels as required. Report all incidents and adverse events to senior staff and enter the information in the CAPA module of Q-pulse in a timely manner as directed by senior staff. Demonstrate on going competency against training plans. Report all incidents and adverse more »
Bristol, Avon, South West, United Kingdom Hybrid / WFH Options
Smartbox Assistive Technology
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 »
M Group Services Limited T/A Morrison Telecom Services
the work Ensure that the products and services we deliver for our clients conform to the specified requirements and agreed standards Advise suitable correctiveandpreventiveaction following the identification of any quality issues Represent as required for customer meetings ensuring customers and companys quality standards are understood and implemented more »
Employment Type: Permanent
Salary: 25 Days Holiday, Pension Scheme, Life Assurance, Staff Benefits
requirements. Work Closely with Mixing and Production in the development of IPC's for new products. Support all site functions with technical investigations andCAPA 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 »
Cardiff, South Glamorgan, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: CorrectiveandPreventiveAction (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance andmore »
internal/3rd party audit methods Experience of managing quality issues across a multi-site organisation Demonstrable experience in resolution of customer complaints andCAPA 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 »
Healthcare. For successful applicants, Polar Speed will process basic disclosure criminal record checks. Key responsibilities: Actively support quality processes such as non-conformance andCAPA 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 »
City Of London, England, United Kingdom Hybrid / WFH Options
Proclinical Staffing
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 »
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 »
Cardiff, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: CorrectiveandPreventiveAction (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance andmore »
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; CorrectiveAction/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 »
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 Correctiveandpreventive 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 »