Beschreibung
Technical/Document Writer - German Speaking - Solothurn, Switzerland
Experience:
- Minimum of 5 years experience as document writer (CAPA/NCR) or similar position.
- Proficiency with a variety of computer software applications in word processing,
Spread sheets, database and presentation (MS Word, Excel, PowerPoint, etc.).
- Compliance experience in the medical device.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Documented training in FDA QSR, ISO required.
Subject Matter Expert (Technical Writer CAPA and NCR):
Duties and Responsibilities:
- With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
- Support to generate the new Standard for process in EU together with SUSA.
- Consultancy and guidance of all employees and Manager regarding CAPA and NCR requirements (external and internal).
- Conduct the team through the RCA for CAPA and NCR.
- Training of all involved employees along the CAPA- and NCR-process.
- Guidance of the CAPA-NCR- process and ensurance of consistant implementation.
- Monitoring of all CAPAs and NCRs.
- Administration and contact person for the CAPA and NCR database.
- Bringing in of improvement proposals, which increase the productivity and efficiency of the CAPA- and NCR- process and provide active support to reach the settled goals
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times.
- Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
- Team player
- Travel required form site to site
- Be able to manage effectively multiple priorities and tasks.
- Work independently and in a team environment.
- Generate SOP as per regulation requested.
- Fluently German mother language/English spoken and written
- Good communication skill