Sartorius MSc Microbiology, Biotech Documentation Specialist Job Opening, Apply Online
Sartorius MSc Microbiology, Biotech Documentation Specialist Job Opening, Apply Online. Exclusive job opportunities for biotechnology and microbiology candidates. Interested Indian nationals can check out all of the details regarding the same below:
Hello again, let’s take a look at the interview questions for the role of Documentation Specialist at Sartorius
Name of the Post – Documentation Specialist
Reference Number – R28361
Employment Mode – Full time
Location – Bangalore
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:
- Master’s degree in biotechnology, microbiology, chemistry or equivalent.
- Minimum 1-5 years’ experience in the 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).
Hello again, let’s take a look at the interview questions for the role of Documentation Specialist at Sartorius
- What is your experience in developing and maintaining detailed databases of appropriate reference materials? Answer: I have experience in developing and maintaining detailed databases of appropriate reference materials by consistently evaluating current content and contributing to the development of approaches for improvement. I also ensure that the documentation is optimized to maintain high documentation flows and standards.
- Could you describe a time when you had to write technical validation documents and what approach did you take to ensure their accuracy and completeness? Answer: Sure, I had to write technical validation documents when I worked on a project at my previous job. To ensure their accuracy and completeness, I first gathered information from project management teams and subject matter experts, and then organized and wrote the documents. Afterward, I reviewed and aligned the technical details in the documents with the project management team and other internal stakeholders, making necessary corrections to ensure their accuracy.
- What is your understanding of Good Documentation Practices (GDP)? Answer: Good Documentation Practices (GDP) is a set of guidelines for ensuring that documentation meets regulatory compliance standards, and that it is accurate, complete, and legible. It is important to follow GDP in the life sciences industry to ensure that there is consistency and reliability in the documentation, which ultimately supports product quality and patient safety.
- What is your experience with working in global environments? Answer: I have experience working in global environments, where I have learned to navigate cultural differences and communicate effectively with team members from different parts of the world. I have worked on projects where I had to collaborate with team members in different time zones, and I have experience using online collaboration tools to ensure that everyone is on the same page.
- Can you describe your approach to continually improving documentation standards and workflow processes? Answer: Sure, I approach continual improvement of documentation standards and workflow processes by regularly evaluating current content and developing approaches for improvement. I also collaborate with the project management team to identify areas for improvement and develop and maintain tracking systems via applicable tools. Additionally, I optimize validation document templates and documentation flows where/when necessary to ensure that documentation processes are streamlined and efficient.
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