Job Details
Job title: Technical Writer Parenteral Process Validation, Drug Product
Employer: Coopers Group AG
Location: Basel
Contract duration: 1 year (will be extended due to on-going projects)
Responsibilities
* Independently write, review and format process validation protocols and reports as well as regulatory documents
* Interpret and understand process validation data as needed to prepare respective documents
* Compile and organize the supporting data and documentation to ensure accuracy, completeness, and consistency in the final PV package and regulatory documents
* Coordinate assigned PV study documents and regulatory submission dossier sections for project teams
* Work on multiple projects and/or project teams in parallel, ensuring timeline adherence in collaboration with project managers
* Apply IT solutions/tools and act as “Superuser” to manage process knowledge and document workflow (e.g., Veeva Quality Docs, Veeva RIM, eVAL, Basecamp 2.0) in support of project teams
Qualifications
* Bachelor’s degree or Master’s degree in a scientific discipline
* 2+ years of experience in Parenteral Drug Product aseptic process development and/or product process validation knowledge, including technical terminology
* 2–5 years of experience in technical writing; experience in regulatory documents is advantageous
* Strong working knowledge of IT tools for text processing, flow diagrams, spreadsheets, and validation documentation workflows
* Ability to quickly learn and convert scientific data into high-quality summaries and reports
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