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 »
Job Title: Senior Quality Evaluator - English plus ( either French, Spanish or German - B2 ) Belfast Onsite Job Description: The role of Senior Quality Evaluator is to coach team members while enforcing policies and driving quality performance, while balancing the need for 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 »
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 »
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 »
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 »
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 »
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 »
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 »
and implement continuous improvement activities across all areas related to countries and regions PV activities to optimise quality and productivity, including process improvement andCAPA 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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
Bishop's Stortford, Hertfordshire, South East, United Kingdom Hybrid / WFH Options
HR GO Recruitment - Bishop's Stortford
quality audits to meet ISO, UK, European and worldwide regulatory requirements. Facilitate quality improvement initiatives. Analyse data for management reviews and non-conformances. Conduct CAPAand non-conformance investigations. Review customer complaints and maintain incident reporting. Meet LSAS objectives and targets. Core Competencies: Experience with BS EN ISO 13485 and … manufacturing environment. Internal and external quality auditing experience to ISO 13485. Passion for quality excellence. Previous quality assurance experience, including QMS documentation. Knowledge of CAPAand root cause analysis tools. Practical problem-solving approach. Understanding of ISO 14971 quality risk management principles. Self-motivated and team-oriented. Ability to manage 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 »
Pulborough, West Sussex, South East, United Kingdom
Terry Parris Associates
findings, and support supplier audits. Update Quality reports and KPIs. Analyze data for quality issues and support improvement initiatives. Initiate CorrectiveandPreventive 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 »
system (Agile); including but not limited to Policies, Manuals, Standard Operating Procedures, Training Instructions and Batch Records. This includes document review and approval. Perform CAPA Coordinator activities; coordination Quality Incidents and Deviations within a Quality Management System (Agile. Proactively contributing to continuous improvement initiatives and other general housekeeping duties. Taking … Design and Manufacture of In-vitro Diagnostics Experience with an Enterprise Resource Planning System (ERP) Experience with Electronic Document Management Systems (EDMS) Experience with CAPA systems - Agile preferred Proficient with MS Word, Excel and Power-Point Join our team and contribute to a dynamic environment where your skills will be more »