Technical Writer
Vor 3 Tagen
ABOUT ARCONDIS
ARCONDIS is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,
information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
MISSION
Tasks and responsibilities
- Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience.
- Proven project-based work experience under GxP guidelines and possess a strong knowledge of those requirements & documentation practices.
- Create educational and training materials-Establish a close collaboration with the software development, product management and customer-oriented to strengthen produced documentation materials.
- Develop documentation materials to support the administration and configuration of our products.
- Observing user feedback to recommend improvements to existing software products.
- Support in writing and translation (from English to German or vice versa) documents.
- Produce high-quality documentation for IT infrastructure processes, procedures, and technical solutions (documents, drawings, slides, etc.).
- Meeting with engineers, programmers, and project managers to learn about specific products or processes.
- Generating Requirement Specification Documents - URS, FS, DS, TS, CS in accordance with GXP regulations.
- Creating Test Specification IQ/OQ/PQ and Application/Validation Qualification Final Report.
STUDIES
**Profile**:
Work experience in the MedTech industry.
Experience in the area of Software as a Medical Device (SaMD) is an advantage.
Knowledge of software systems and frameworks including Git, GitHub,.NET, Tessy, etc.
Knowledge and strong experience in software and App development.
Familiarity with Agile development technologies.
Ability to work as part of a team or individually on a project.
Knowledge of/work experience in cGMP environment and familiarity with Technical Change Control.
Familiarity with maintenance processes and documentation, such as work orders, operating procedures and work instructions.
Ability to interpret Quality standards for implementation.
Ability to independently evaluate situations and propose potential solutions.
Ability to communicate clearly and professionally both verbally and in writing.
Fluency in English (C1 level minimum)
Along with your CV, please also send us samples of your work.
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