Beschreibung
We are searching for a Quality Assurance Expert for 12 months project to ensure technical development and manufacturing operations of assigned Medical Devices/Combination Products.
Major Accountabilities
. Manage portfolio of assigned projects and provide a service functional expertise in area of responsibility for medical devices and combination products.
. Write, Review and approve deliverables (eg procedures, records, third party work, contractors, clinical trial material, components) and related tools (eg 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 and technical matters and ensure they are resolved consistently and in accordance with global standards and policies.
. Release medical devices for clinical studies and commercial use.
. Support Medical Device Risk Management, through proactive risk management tools and approaches,
. Represent the department in initiatives and cross-divisional projects.
. Lead project related activities (eg development of new tools, processes).
. Perform and support inspections and audits as required.
. Provide support to other line functions in GMP compliance related issues in area of Medical Device standards
. Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority requirements, SOPs, HSE, etc.)..
. Support project management functions in preparation for a Pre-Approval Inspection.
. Write/contribute to internal compliance policy and/or comment to regulations.
Requirements:
. University degree in a relevant subject
. Work experience in the pharmaceutical or medical device industry
. Experience in planning and writing technical documentation for Medical Devices and combination Products
. ISO 13485, ISO14971, MDD and QMS for Medical Devices
. Experience with Medical Device Design Control
. Ideally experience in the field of Auto-Injectors and Safety Devices
. Excellent communication skills in German and English
. Excellent Project Management skills
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.