Beschreibung
Subject Matter Expert
Pharmaceutical Sector
Must Speak English and German for the opportunity
Switzerland
Contract
Competitive Daily Rates
Subject Matter Expert:
Responsibilities:
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Ensure availability and correctness of packaging documentation for sterile and non-sterile medical devices, in compliance with all valid regulations (ISO, FDA, etc.)
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Check packaging configurations (Bill of material) and packaging validation documentation (package transit qualification, packaging shelf life) in PLM/ERP systems and verify their correctness
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Perform updates/changes (DCR/DCO) for non-conforming packaging documents and Bill of Materials in the systems (Agile/SAP)
Personality:
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Technical understanding (drawings, processes, packaging specifications and materials, validation standards, etc.)
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Fluent German spoken and written English is an advantage
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Be able to work with various databases to extract and report out required information (Excel, Access, Agile, SAP etc.)
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Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times
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Excellent organizational skills (meet due dates), readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
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Team player
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Be able to manage effectively multiple priorities and tasks
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Eye for detail
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Self-motivation for repetitive work
Experience:
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2 years' work experience in an adequate position and regulated industry preferred
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Prior experience in medical device/pharmaceutical remediation preferred
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Background on validation procedures and packaging technology helpful
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Proficient in the use of spreadsheet software (Access/Excel etc.)
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Thorough understanding of GMP guidelines
Non-Technical profile requirements:
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Some flexibility in working hours is required
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Must be able to work on multiple simultaneous tasks with limited supervision
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Excellent customer service, interpersonal, communication and team collaboration skills
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Able to follow change management for internal guidelines
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Strong knowledge and skills in MS Office
Language proficiencies:
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English and German spoken and written