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Medical Device Packaging Technology Expert - Oferta z Jobs.pl

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Medical Device Packaging Technology Expert

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  • Medical Device Packaging Technology Expert - 9 Month Contract-Immediate Start- Switzerland Level: Medical Device Packaging Technology Expert Contract: Minimum 9 Month Contract Salary: Negotiable Location: Switzerland Summary A leading pharmaceutical company is looking for a senior consultant to manage packaging and design activities. The successful candidate will be involved in technical development of medical device and combinations products with a strong focus on packaging technology and other related activities. Responsibilities * Advanced knowledge in packaging material and design for medical devices and combination products * Responsible for planning, designing and performing relevant activities according to assigned projects * Knowledge in areas of materials (polymers, rubbers, silicone/lubricants, adhesives, sterile barrier systems) * Manufacturing knowledge (injection moulding, glass converting, rubber moulding, assembly, fill&finish, transport validation) * Responsible for working to relevant internal and external regulatory standards to ensure compliance (SOP's, GMP, HSE, ISEC) * Responsible for preparing protocols, data interpretation and report writing * Responsible for verification activities including shipping verification * Responsible for timely completion of risk management files as well as management of risk management program of packaging and device development activities * Responsible for the design control process and other applicable regulatory, QA and GMP aspects * Review and author relevant DHF documents and contribute to quality DHF file. * Strong technical knowledge of parenteral packaging as well as medical device development * Good knowledge of Human Factors Engineering/ Usability activities * Excellent understanding of Medical device regulations (FDA 21CFR 820, ISO13485, and ISO 14971, EU medical directive) to be applied to relevant projects Qualifications * Minimum 3 years' industry experience * Degree in applicable field (Engineering, Mechanical engineering) * Fluent in spoken and written English (other European languages are a bonus) * Excellent understanding of Medical device regulations * Strong understanding of packaging and device development Please feel free to make an application or to find out more please contact: Amie Touray (0)#LI-AT1


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