Description
We are looking for a
Medical Device Compliance & Quality System Documentation Specialist (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Dealing with COREMAP Requirements in Device Development for documents, adopt documents to archival requirements and cleanup activities
- Support the Documentation and Compliance Group in preparing
- Documents for Quality System Documentation, establish and maintain Technical Documentation according requirements outlined in the Medical Device Directive and 21 CFR820 for Medical Devices and Design History Files
- Training administration
- Actively contribute to improvement of documentation management systems, business processes and procedures, ensure Good Documentation Practices
- Perform any other tasks as requested by Management to support
- Documentation and Compliance activities
Your qualifications
- Experience in working in pharmaceutical, biotech, diagnostics, medical device or healthcare industry under cGxP, QSR or similar working practices
- Excellent knowledge of cGMP`s and relevant international regulatory requirements, quality system experience
- Excellent documentation management and documentation skills
- Sound knowledge of Quality Systems Regulations including device design controls, and Medical Device Directives (e.g. ISO 13485 and FDA CFR 21 Part 11, Part 820)
- Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing
- Excellent IT knowledge
Skills:
- Quality manager
Keywords: Qualitätsmanager