This position will be responsible for ensuring the compliance and quality of technical development and manufacturing operations of assigned Medical Devices/Combination Products.
Your daily tasks:
* Write, Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance. * Accountable for monitoring, analysis and reporting of GMP related KPIs as part of management reporting. * Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies. * Release of medical devices for clinical studies and commercial use. * Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients. * Lead project related activities (e.g. development of new tools, processes). * Perform or support inspections and audits as required. * Coach and develop people; participate in recruitment of talent. Support a culture of high performance and trust. * Support project management functions as a sub-team member in preparation for a Pre-Approval Inspection. * Write/contribute to internal compliance policy and/or comment to regulations.
Degree in life science discipline
scientific, technical and regulatory knowledge and experience related to medical devices/combination devices Excellent knowledge of cGMP, quality assurance, manufacturing and auditing processes Good knowledge of medical device development and life-cycle management. Good organizational skills. Good and proven ability to analyse and evaluate GMP compliance.
Please send your CV
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