DP Parenteral Process Validation Technical Writer and Document Workflow Manager

Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.

For our client F. Hoffmann - La Roche in Basel, we are looking for a motivated and reliable (m/f/d)

• 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 that accuracy, completeness, and consistency are maintained in the final PV package and regulatory documents (Compliance of internal and external documents)
• Work on multiple projects and/or project teams in parallel (dependent on complexity and time commitment for each project) ensuring timeline adherence in collaboration with project managers
• Coordinate assigned Process Validation (PV) study documents and regulatory submission dossier sections for project teams.
• Apply IT solutions/tools and act as "Superuser" to manage process knowledge and document workflow (e.g., Veeva Quality Docs, Veeva RIM, eVAL Roche, Basecamp2.0) in support of project teams.

• Bachelor's degree or Master's degree in a scientific discipline
• 2+ years experience within the 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 writing of regulatory documents is of advantage
• Excellent command of English is required
• Superior working knowledge and affinity to IT tool to manage text processing, flow diagram and spreadsheet applications as well as validation documentation workflows ***
• Ability to learn fast, grasp the 'essence' of a strategy or a story quickly to convert relevant scientific data/information into high quality summaries and reports
• Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects
• Ability to take high degree of initiative and demonstrates motivation to work independently and be a self-starter
• Team and solution oriented with flexibility in prioritization