Junior Subject Matter Expert

For a 6 month project with our client in Solothurn, we are looking as soona as possible for a JUNIOR 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
- Quick learner, motivated self-starter
- 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