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 »
audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors. Execute validation protocols and drive to completion any CAPA associated with non-conformances raised. Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed. more »
audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors. Execute validation protocols and drive to completion any CAPA associated with non-conformances raised. Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed. 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 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 »
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 »
