Posted on Aug 27, 2019 by Stamford Consultants AG
- Ensure availability and correctness of packaging documentation for sterile and non sterile medical devices, in compliance with all valid regulations (ISO, MDR, FDA, etc.)
- Check packaging configurations (Bill of material) and packaging validation documentation (package transit qualification, packaging shelf life) in 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)
POSITION DUTIES & RESPONSIBILITIES:
- Plan, schedule and track project timelines using appropriate tools.
- Responsible to originate/oversee/assist in the creation & release of change orders (COs) for all packaging related change requests through Agile PLM software.
- Technical understanding (drawings, processes, packaging specifications and materials, validation standards, etc.)
- Initiate, route, verify and handle all the administrative paperwork and formalities in coordination with multiple departments stakeholder contacts.
- Additional duties as assigned.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- 2 years' work experience in an adequate position and regulated industry preferred
- Experience in an Medical Device regulated environment
- Background on validation procedures and packaging technology
- Proven exceptional written and oral presentation skills
- Bachelor's degree in business, information systems or related discipline, or equivalent and extensive related project experience.
- Certificates in Program/Project Management will enhance candidacy but are not a
- Strong knowledge and skills in MS Office
- Knowledge and skills in PLM system, ex. Windchill, Agile, Adaptive, SAP will enhance candidacy
- Must be highly organized, creative, articulate and analytical
- Strong interpersonal and diplomatic skills
- Ability to multi-task independently with minimal supervision
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