Description
Subject Matter ExpertPeriod: to
Location: Central Switzerland
Subject Matter Expert (Acceptance Activities):
On behalf of our client, an international company specialized in the medical devices we are looking for a Subject Matter Expert with previous experience working in the medical devices sector.
Responsibilities:
Your duty requires to assure the availability and correct completed packaging documentation for sterile and non-sterile medical devices, in compliance with all valid regulations
(ISO, FDA, etc.)
Furthermore you review and verify the packaging configurations (Bill of material) and packaging validation documentation (package transit qualification, packaging shelf life)
in PLM/ERP systems
In addition you perform updates/changes (DCR/DCO) for nonconforming packaging documents and Bill of Materials in the systems (Agile/SAP)
Experience:
- Two years work experience in an adequate position and regulated industry preferred
- Thorough understanding of GMP guidelines
- Prior experience in medical device / pharmaceutical remediation preferred
- Background on validation procedures and packaging technology required
- Proficient in the use of spreadsheet software (Access / Excel etc.)
Your profile:
- Advanced knowledge of the guidelines relating the code of conduct, ethics and compliance programs and other relevant regulations at all times
- Technical understanding (drawings, processes, packaging specifications and materials, Validation standards, etc.)
- Ability to work with various databases to extract and report required information, strong knowledge and skills in MS Office (Excel, Access, Agile, SAP etc.)
- Excellent organizational skills (meet due dates), readiness to take on responsibility, reliable, proactive & self-driven, excellent collaborative and communication skills, customer oriented
- Team player & able to manage effectively multiple priorities and tasks
- Some flexibility in working hours is required
- Able to follow change management for internal guidelines
- Language proficiencies:
- English and German spoken and written
If this outstanding opportunity sounds interesting to you or for more information on this or other opportunities, please do not hesitate to contact Sabina Keel at Real Staffing on or or feel free to send me your CV.
Validation, packaging, medical device, QA, quality assurance, subject matter expert, Switzerland