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./li li Coordinates or leads investigations in Quality and other loss control incidents in Seed Manufacturing./ 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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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
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 »
Petersfield, Hampshire, South East, United Kingdom
Sierra 57 Consult
appropriate problem-solving tools. Conduct drawing and specification reviews as part of feasibility studies. Drive quality improvement throughout the business, using 5 Why, FMEA, CAPAand 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 »
To conduct investigations to assess the probable root cause of any deficiency noted during process confirmation activities, informing the accountable function, and ensuring correctiveandpreventiveaction is taken. Required Skillset: To succeed in this position, you must have the ability to interpret drawings and be able to problem solve 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 »
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 »
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 »
attend study days and training programs as requested by Senior Technician, ASU to ensure continuing personal development. To highlight potential correctiveand preventable actions (CAPA) and service improvements to enable colleagues to learn from errors or quality issues. To undertake any other related duties as may be deemed necessary. To … within an aseptic unit Experience of creating debtor forms, dealing with invoice queries. Experience of conducting risk assessments and COSHH assessments Experience of implementing CAPA Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary more »
Leighton Buzzard, Bedfordshire, South East, United Kingdom
Polar Speed Distribution Ltd
Key responsibilities: Responsible Person and Responsible Person for Import Actively assist in the implementation and maintenance of quality processes such as non-conformance andCAPA management, change controls and risk assessments, and ensure that the quality system is continuously improved with the objective of assuring GDP compliance Provide support for … are maintained, and seasonal mapping and calibration activities are conducted in a timely manner Host and participate in regulatory and client audits and prepare CAPA plans addressing any observations identified Key Skills/Experience/Requirements: Successful candidate MUST be eligible to become a Responsible Person for Import. Exceptional knowledge more »