Beschreibung
Our client, a major global player is currently looking for a packaging specialist, estimated starting date March 2015 until end of December h/40h a week), with possible extension.
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) Skillset:
- 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
- Excellent organizational skills (meet due dates), readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
- Team player
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
If you are looking for a new challenge, don't hesitate to send your application (max. 5 pages, Word format) in English, stating your detailed skills to me.
I am looking forward to receiving your applications
Olivier Worch