Beschreibung
Technical Writer CAPA & NCR
Edelway AG is a Professional Services Consultancy based in Switzerland. One of our best clients, a global pharmaceutical company, based in the Bern/Basel area, is currently looking for a Technical Writer CAPA & NCR to join them on a long term basis (contract or permanent).
Language: English, German is a plus
Start Date: ASAP
Rate: Excellent
THE ROLE
*Oversee the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc).
*Help generate the new process standard for the EU in conjunction 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 the employees involved in the CAPA and NCR process.
*Guiding the CAPA/NCR process and ensuring its consistent implementation.
*Monitoring all CAPAs and NCRs.
*Administration and contact person for the CAPA and NCR database.
*Presenting and creating improvement proposals to increase the productivity and efficiency of the CAPA/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.
YOUR PROFILE
*Minimum of 5 years experience as document writer (CAPA/NCR) or similar position.
*Proficiency with a variety of computer software applications in word processing,
Spreadsheets, 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.
*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 effectively multitask and prioritise a number of different projects
*Work well both independently and in a team environment.
*Generate SOP as per regulation requested.
If this sounds like your next challenge send us your CV and we will call you to discuss the role in more details.