9 of 9 CAPA Jobs in the South East

regulations, with good understanding of EU GMP requirements and clinical trial manufacturing expectations. In-depth understanding of Quality Management Systems, including deviation investigations, CAPA management, change control and risk management processes. Strong experience reviewing manufacturing and quality documentation, including batch records, specifications, protocols and reports. Demonstrated ability to lead ...

experience in Complaints Management for Medical Device Strong understanding of FDA, EU MDR/IVDR requirements and Reporting Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability ...

technology-based environment. Knowledge of quality management systems, supplier development, and continuous improvement methodologies. Experience with root cause analysis, corrective and preventive actions (CAPA), and supplier performance management. Ability to work collaboratively with suppliers, EMS partners, and cross-functional teams to drive quality improvements and operational excellence. Experience working with ...

and approval of project Validationdocumentation according to applicable approval matrix or procedures Supports quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management Writes and manages validation plans, ensuring appropriate, timely validation/revalidation is maintained Conducts internal audits and assists with ...

and maintain manufacturing engineering standards, methods and best practices Facilitate root cause investigations and structured problem-solving using methodologies such as 8D, DMAIC and CAPA Lead and facilitate the site Continuous Improvement programme including training, coaching and project delivery Manage CAPEX budgets and departmental expenditure, including preparation of business cases ...

procedures, and manufacturing documentation. Collaborating closely with QA peers for timely closure of documentation related to commercial batch disposition. Participating in investigations (RCA) and CAPA tasks to address deviations and compliance issues. Utilizing performance tools in collaboration with the team to meet operational KPI objectives. Responding to and troubleshooting routine ...

/PCBA manufacturing knowledge IPC-A-610 and/or J-STD-001 experience AS9100 and/or ISO 9001 experience Root Cause/CAPA/8D/FMEA experience ERP/MRP experience Hands-on measurement, inspection and test equipment knowledge These requirements closely reflect the essential experience identified ...

Management of Quality Reviews – Monthly Compilation and presentation of KPIs for Key business functions required supporting Management reviews. Raise, monitor, and verify CAPA/8D, working with relevant stake holders to drive robust RCCA. Compilation and maintenance of company documentation Maintenance of training material and deployment of training Drive ...

function in cross-functional projects and procedural documentation (SOPs, GDLs, WIs) Own audit and inspection readiness for case intake, including corrective and preventive action (CAPA) management Experience Required A degree or equivalent professional background in a life sciences discipline (Registered Nurse, BS/BA, Physician Assistant, Pharmacist, or medical documentarian ...