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Technical Writer CAPA & NCR
Eingestellt von Edelway
Gesuchte Skills: Support
Projektbeschreibung
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 13485/9001 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.
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 13485/9001 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.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges