Beschreibung
GDP Technical WriterDuration: 6 months with possible extension
Location: Canton of Vaud, Switzerland
Responsibilities:
This position will be responsible for writing technical documentation and ensuring the good documentation practice (GDP) with high quality level which is required in the sectors of pharmaceutical, medical devices development sectors. Being part of an energetic team, the skills in quality assurance, software development projects, process execution and compliance to regulations will be key to ensure the position responsibilities. Professionalism, and willingness to contribute to the progress of the documentation activities of the team will be highly appreciated.
- Writing technical documentation with very high-quality level
- Controlling and improving the level of quality of the existing documents
- Strong interactions with the team to ensure the adequation with the medical device software or applications and their associated devices or products
- Following Good documentation practices
- Ability to be autonomous in the redaction with analytical skills and to communicate with the team
- Ensuring the documentation list according to the process
Candidate Profile
- 5+ years of good documentation practice in medical or pharmaceutical sectors
- Knowledge in methodology and practices in software development
- Very strong skills in Microsoft Office (Word, Excel)
- Strong experience in writing technical documents (GDP): SOP, Requirements, Specifications, etc.
- Good experience in writing documentation for medical device development
- Experience with Application Requirements Management software or Document Management software (Polarion, Jama, Jira, IBM, Mango, Agile, etc.)
- Rigorous and focusing on high quality level of documentation writing
- Energetic, teamwork mindset, adaptability and flexibility
- Good Knowledge in MDD, MDR, Risk Assessment, Traceability Matrix
- MS degree in Quality, or Biomedical Engineering, or related field
- Fluent in English, fluency in French is an advantage
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.