Documentation Specialist Validation Services
Location
Bangalore | India
Job description
For Sartorius Stedim India Pvt. Ltd., we are looking for Documentation Specialist to join our team in Bangalore. In this role, you will support in documentation related activities for Confidence Validation Services (single-use components like filters) based on technical details furnished by project management team to meet customer and regulatory requirements. Development and maintenance of systems for tracking documentation processes and workload on periodic basis. Updating databases and collaboration with project management team for continual improvement of documentation standards and workflow processes.
Sartorius Confidence® Validation Services provides services to customers in the (bio)pharmaceutical industry with focus on validation of filter and single-use applications.
What You Will Accomplish Together With Us - Preparation and review of scientific and technical validation documents (can include but not limited to statements, protocols and reports) in English
- Alignment of technical details in the validation documents with project management team and other internal stakeholders (as necessary) in a timely manner
- Independently gather information from project management team and subject matter experts to organize and write Validation documents
- Optimize validation document templates and documentation flows where/when necessary
- Develop and maintain detailed databases of appropriate reference materials.
- Evaluate current content and contribute to development of approaches for improvement
- Develop and maintain tracking systems via applicable tools and provide monthly summary report
What Will Convince Us - Masters degree in biotechnology, microbiology, chemistry or equivalent.
- Minimum 3-5 years' experience in life science industry.
- Previous experience writing documentation and procedural materials for multiple audiences.
- Knowledge on the concept of microbiology is preferred. Knowledge on filtration / Extractables / Leachables / related analytical methods, e.g. HPLC-UV, GC-MS, LC-MS is a plus.
- Understanding of drug manufacturing processes and pharmaceutical industry regulatory requirements ( FDA, EMA, WHO etc.) is a plus.
- Familiar with concept of GMP and GDP (Good Documentation Practices)
- Experienced with working in global environments is a plus.
- Excellent written and verbal communication skills in English with an eye for detail.
- Excellent knowledge of Microsoft Office applications (Word, Excel, PowerPoint).
About Sartorius Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
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