Beschreibung
We have an exciting opportunity for a global pharmaceutical company to join a project in remediation and inspection readiness. This is initially 3 months contract - may be extended.Tasks:
* Prepare training materials & conduct training to associates to achieve knowledge to medical devices Quality Management Systems, regulations and Novartis policies
* Update and create process storyboards, audits presentations, audit playbook to assure clear processes and linkages.
* Create complex process graphs, using visuals and workflow
* Write and explain processes in a clear, concise and efficient manner
* Interact with process Subject Matter Expert (SMEs) in the frame of process description
Requirements:
* Meet quality and timelines in the Inspection Readiness Roadmap
* Act in accordance with required standards: GMP, ethical, Health Safety and Environment (HSE), Information Security (ISEC) and Code of Conduct
* strong experience in internal or external audits from the medical device industry
* Knowledge of ISO 13485, FDA QSR, MDR, MDSAP, SaMD standards.
* Excellent communication skills in English, both written and spoken
Michael Bailey International is acting as an Employment Business in relation to this vacancy.