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Sartorius Exclusive Job – Hiring Msc Biotech Microbiology
Job Title: Documentation Specialist Validation Services
Reference Number | RefNo: R28361
Location: Bangalore (India)
Employment Type: Full-time, Regular
Sartorius Stedim India Pvt. Ltd. is seeking a Documentation Specialist to join our team in Bangalore. We are a leading provider of Confidence Validation Services in the (bio)pharmaceutical industry, specializing in the validation of filter and single-use applications. As a Documentation Specialist, you will play a crucial role in supporting documentation related activities to meet customer and regulatory requirements.
Responsibilities:
Preparation and Review of Documents:
– Prepare and review scientific and technical validation documents, such as statements, protocols, and reports, in English.
Alignment of Technical Details:
– Collaborate with project management team and internal stakeholders to ensure technical details in the validation documents are aligned.
Gathering Information:
– Independently gather information from the project management team and subject matter experts to organize and write validation documents.
Optimization of Document Templates:
– Optimize validation document templates and documentation flows as required.
Database Development and Maintenance:
– Develop and maintain detailed databases of appropriate reference materials.
Process Improvement:
– Evaluate current content and contribute to the development of approaches for improvement.
Tracking and Reporting:
– Develop
and maintain tracking systems using applicable tools and provide monthly summary reports.
Educational Requirements:
- Master’s degree in biotechnology, microbiology, chemistry or equivalent.
- Minimum 1-5 years’ experience in life science industry.
- Previous experience writing documentation and procedural materials for multiple audiences.
- Knowledge of microbiology concepts preferred. Knowledge of filtration, extractables, leachables, and 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.
- Familiarity with concepts of GMP and GDP (Good Documentation Practices).
- Experience 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).
How To Apply:
To apply for this position, please visit the link.
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Having intrest in this feild.
Microbiology is a very demanding course now a days.this subject is very much demand in india and abrods.
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