1 to 3 of 3 Permanent Change Control Jobs in Swindon

Manager & RP in ensuring that a quality management system (QMS) is implemented and maintained including quality risk management, documentation management, non-conformance and CAPA, 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 … 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 … Establish, implement and support the maintenance of the Labour Standards Assurance Scheme (LSAS) Support the change control process. Give QA oversight and provide support to activities within the company (UK) Support the risk management process and liaise with key stakeholders to reduce or mitigate any identified risks. Maintain more »

from experienced professionals and launch your own career path within a business that is going places. RESPONSIBILITIES Support in the development, implementation, maintenance and control of on-going (or future) compliance to all certifications and standards relevant to the company. These will include as a minimum: ISO13485 (including EU … Actively participates and/or drives Quality System improvements as required. Supports continuous improvement initiatives, process improvements to address operational issues using statistical process control (SPC) and Quality tools e.g. pareto, process capability, correlation analysis, etc. Performs internal and supplier audits as required. Uses auditing as a proactive tool … as SME during external regulatory audits. Strong knowledge and experience of CAPA and NC for medical devices A practical working knowledge of implementation of change control, and of all aspects of the process and equipment validation lifecycle Desirable Requirements Knowledge and experience of PowerPoint and SAP and SPC more »

part of a dedicated team. Keywords: Quality, QA, assurance, GMP, manufacturing, distribution, packaging, CDMO, pharmaceutical, batch release, systems, compliance, regulatory, specialist, investigations, CAPA, deviation, change control, operations, senior, leader, supervisor, manager, coach, mentor. more »