Non conformances and CAPA using root cause analysis tools where appropriate and regular reporting on NCs and CAPAs. Responsible for NC and CAPA process management and regular reporting of KPIs Deputise for the QARA Manager & RP where appropriate Support the QA/RA Manager & RP in ensuring that a … quality management system (QMS) is implemented and maintained including quality risk management, documentation management, non-conformance and CAPA, changemanagement, deviation processes, internal and supplier approval and audits as well as measurement of performance indicators and management review Take ownership for assigned projects and … for accuracy and compliance with cGDP and MDD/MDR. This will include, but is not limited to, review of project documents, specifications, BOMs, change controls, validation protocols and standard operating procedures (SOPs), custom pack documentation & packaging submissions. To support the supplier assurance program including the approval of suppliers more »
standards and striving for excellence across all project facets. • Oversee the opportunities and risk assessment process, ensuring thorough utilization of ARM (Asset and Risk Management), and conduct regular reviews accordingly. • Maintain, review, and update the project schedule in alignment with project specifications. Collaborate with relevant section managers to identify … deviations from planned outputs, devise improvement strategies, and address commercial considerations. • Ensure adherence to the projects changemanagement protocols as per contractual, sub contractual, project, and organizational guidelines. Optimise commercial prospects while fostering sustainable relationships with stakeholders. • Assist the company in achieving corporate objectives, strategies, and initiatives spanning more »
based on predicted requirements. Contribute to the engineering design, development and implementation of new and existing equipment, and comply with the needs of the changemanagement process for the plant. Ensure the working environment is safe and in a clean condition, including organising periodic cleaning of operational and … welfare areas. Use of the stock management system to ensure that key stocks and consumables are maintained at appropriate levels, reporting any stock shortage or equipment failures or other deficiencies in a timely manner to permit early resolution. Preparation of and recording quantities of all materials needed (inc. chemicals more »
