DP Parenteral Process Validation Technical Writer and Document Workflow Manager (m/f/d)
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 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
Profile
- Bachelor’s degree or Master's degree in a scientific discipline
- Hands-on experience within the Parenteral Drug Product aseptic process development and/ or product process validation knowledge including technical terminology
- 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
Benefits
- Unlimited project contract
- Fascinating, innovative environment in an international atmosphere
About Hays
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and suitable positions and projects.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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