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Subject Matter Expert | Pharmaceutical Sector | Switzerland
Eingestellt von Templeton and Partners
Gesuchte Skills: Sap, Plm
Projektbeschreibung
Subject Matter Expert
Pharmaceutical Sector
Must Speak English and German for the opportunity
Switzerland
Contract
Competitive Daily Rates
Subject Matter Expert:
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
Non-Technical profile requirements:
-
Some flexibility in working hours is required
-
Must be able to work on multiple simultaneous tasks with limited supervision
-
Excellent customer service, interpersonal, communication and team collaboration skills
-
Able to follow change management for internal guidelines
-
Strong knowledge and skills in MS Office
Language proficiencies:
-
English and German spoken and written
Pharmaceutical Sector
Must Speak English and German for the opportunity
Switzerland
Contract
Competitive Daily Rates
Subject Matter Expert:
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
Non-Technical profile requirements:
-
Some flexibility in working hours is required
-
Must be able to work on multiple simultaneous tasks with limited supervision
-
Excellent customer service, interpersonal, communication and team collaboration skills
-
Able to follow change management for internal guidelines
-
Strong knowledge and skills in MS Office
Language proficiencies:
-
English and German spoken and written
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
SAP Entwicklung, Ingenieurwesen/Technik