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Subject Matter Expert - up to 700 CHF - German Communication Skill
Eingestellt von Templeton and Partners
Gesuchte Skills: Sap, Plm
Projektbeschreibung
Your Responsibilities:
- Ensure availability and correctness of PACKAGING documentation for sterile and non-sterile MEDICAL DEVICES, in compliance with all valid regulations (ISO, FDA, etc.)
- Check packaging configurations (Bill of material) and packaging validation documentation (package transit qualification, packaging shelf life) in PLM/ERP systems and verify their correctness
- Perform updates/changes (DCR/DCO) for non-conforming packaging documents and Bill of Materials in the systems (Agile/SAP)
Personality:
- Technical understanding (drawings, processes, packaging specifications and materials, validation standards, etc.)
- Fluent German spoken and written English is an advantage
- Be able to work with various databases to extract and report out required information (Excel, Access, Agile, SAP etc.)
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times
- Excellent organizational skills (meet due dates), readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
- Team player
- Be able to manage effectively multiple priorities and tasks
- Eye for detail
- Self-motivation for repetitive work
Experience:
- 2 years' work experience in an adequate position and regulated industry preferred
- Prior experience in MEDICAL DEVICE/PHARMACEUTICAL remediation preferred
- Background on validation procedures and packaging technology helpful
- Proficient in the use of spreadsheet software (Access/Excel etc.)
- Thorough understanding of GMP guidelines
- Ensure availability and correctness of PACKAGING documentation for sterile and non-sterile MEDICAL DEVICES, in compliance with all valid regulations (ISO, FDA, etc.)
- Check packaging configurations (Bill of material) and packaging validation documentation (package transit qualification, packaging shelf life) in PLM/ERP systems and verify their correctness
- Perform updates/changes (DCR/DCO) for non-conforming packaging documents and Bill of Materials in the systems (Agile/SAP)
Personality:
- Technical understanding (drawings, processes, packaging specifications and materials, validation standards, etc.)
- Fluent German spoken and written English is an advantage
- Be able to work with various databases to extract and report out required information (Excel, Access, Agile, SAP etc.)
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times
- Excellent organizational skills (meet due dates), readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
- Team player
- Be able to manage effectively multiple priorities and tasks
- Eye for detail
- Self-motivation for repetitive work
Experience:
- 2 years' work experience in an adequate position and regulated industry preferred
- Prior experience in MEDICAL DEVICE/PHARMACEUTICAL remediation preferred
- Background on validation procedures and packaging technology helpful
- Proficient in the use of spreadsheet software (Access/Excel etc.)
- Thorough understanding of GMP guidelines
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Ingenieurwesen/Technik