Sartorius
Location
Bangalore | India
Job description
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).
Job tags
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