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 »
that an escape occurs, the engineer also makes sure that the proper root cause investigation is conducted and that planned, tested, and implemented correctiveandpreventiveaction is taken. Experience/Skills: Extensive knowledge and experience with statutory regulations for global market products, particularly electrical/electronic systems. Ability to 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 »
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 »
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 »
Caernarfon, Gwynedd, Wales, United Kingdom Hybrid / WFH Options
Siemens Healthineers
regulatory requirements, and ensure business needs are met through the delivery and operation of vigilance and post market activities, internal and external audits andCAPA System. This is a home-based role (#LI-REMOTE) with occasional travel to our site in Llanberis. Your Role: You will provide support for post … market activities and representation on various product related meetings. You will be responsible for the effectiveness of CAPA, internal/external audits, input to Management Review at site level. You will support corporate QM function with site vigilance activities. You will support the site with internal and external investigations/ 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 »
Loughborough, Leicestershire, East Midlands, United Kingdom Hybrid / WFH Options
Almac Group (Uk) Ltd
Analytical Team Leader (Raw Materials) Hours : 37.5 hours per week worked over a flexible work pattern Salary : Competitive and dependent on experience and suitability Ref No : HRJOB8642 Business Unit : Pharma Services Location : Loughborough, Leicestershire Open To : Internal and external candidates 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 »
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 »
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 »
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 »
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 »
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 »
effectiveness of the Full Support Healthcare QMS Maintenance and communication where required of technical documentation Investigate and report on non-conformances, customer complaints andCAPA issues within specified timeframes Validation of sterilisation and packaging processes Arrange required product testing and review test reports Validation of sterilisation and packaging processes Completing more »
Bishop's Stortford, England, United Kingdom Hybrid / WFH Options
HR GO Recruitment
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 »
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 »
text, colour and size). Create a Q. C. bag Verify and print out bar codes Have a good Understand and help manage the CAPA/Improvement Process Understand and follow the Quality Process Flow Chart, including CCP's Conduct internal Audits as per the internal audit schedule Ensure finished … training of new personnel Assist the Quality Assurance Manager with other relevant tasks Respond to customer complaints in a timely manner Raise and issue CAPA numbers and forms for non-conforming products with suppliers Conduct calibration tasks as per the calibration schedule 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 »
Basingstoke, England, United Kingdom Hybrid / WFH Options
Blatchford
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 »
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 »
assess external customer complaints in the global Elanco complaint system including the evaluation of the complaint investigation for correctness and an assessment of proposed CAPA within the due time periods. • To maintain a batch record review qualification status of contract manufacturers. • To monitor and to drive EEM-EMEA CAPA system. more »
Teams & email communications regarding product quality Telephone, MS Teams & email communications regarding ongoing product/process improvement activities Telephone, MS Teams & email communications regarding CAPA activities Other Telephone, MS Teams & email communications as deemed required by the Quality Manager at the Dundee site Draft/update/improve supplier quality … well as NCMR/CARs assigned by or to other Smiths Interconnect sites. SUPPLIER Quality & Development – Partner with supply chain in adequate completion of CAPA requests due to nonconforming or discrepant material. Collaborate with regularity ensuring supply chain partner are engaged in continual improvement activities. MRB ACTIVITIES - Coordination of MRB more »