Sartorius Project Opening For MSc Biotech & Microbiology, Apply Online
Sartorius Project Opening For MSc Biotech & Microbiology, 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 Project Coordinator Validation Services at Sartorius
Name of the Post – Project Coordinator Validation Services
Reference Number – R28325
Employment Mode – Full time
Location – Bangalore
For Sartorius Stedim India Pvt. Ltd. we are looking for Project / Program Coordinator to join our team in Bangalore. In this role, you will be responsible for Coordination of Bioprocess Validation Projects with a focus on filter validation for the local market based on customer and regulatory requirements while ensuring close involvement of customers and internal stakeholders. 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:
- Understand customer requirements and concerns.
- Coordination of validation projects on behalf of customers in a timely manner according to the agreed test scenario as well as in compliance with regulatory requirements (e.g. FDA, EMA, WHO).
- Preparation of quotes for different test scenarios / scopes.
- Customer visits and travel as and when necessary (e.g. acquiring new projects, presentation of Validation Services, generating validation leads) (less than 10%)
- Ensure efficient and effective completion of validation projects under consideration of complexity and time in coordination with the sales team, the customer and the validation lab(s).
- Preparation, review and approval (based on necessity) of scientific and technical validation documents (statements, protocols, reports and other documents) in English.
- Track all validation leads and projects via applicable tools and provide monthly summary report.
What will convince us:
- Master’s degree or above in biotechnology, microbiology, chemistry or equivalent
- Minimum 2-5 years experience in Validation Services, Filtration or the life science industry.
- Knowledge of microbiological aspects
- Familiar with the concept of GMP and GDP (Good Documentation Practices)
- Knowledge of the concept of Extractables / Leachables and related analytical methods, e.g. HPLC-UV, GC-MS, LC-MS is a plus.
- Understanding drug manufacturing processes and pharmaceutical industry regulatory requirements ( FDA, EMA, WHO etc.) is a plus.
- Excellent interpersonal skills and ability to work in a Global environment.
Hello again, let’s take a look at the interview questions for the role of Project Coordinator Validation Services at Sartorius
- What are the primary responsibilities of a Project Coordinator Validation Services? Answer: A Project Coordinator Validation Services is responsible for coordinating validation projects for customers in a timely manner according to the agreed test scenario, preparing quotes for different test scenarios, ensuring efficient completion of validation projects in coordination with sales team, customers, and validation labs, and preparing, reviewing, and approving technical validation documents.
- What is your experience in Validation Services or the life science industry? Answer: I have 5 years of experience in the life science industry, with 3 years of experience in Validation Services.
- Can you explain your knowledge of microbiological aspects and its relevance to validation projects? Answer: Microbiological aspects are relevant to validation projects as they help in understanding the microbial contamination risks during the manufacturing process and the potential impact on the product quality. My knowledge of microbiology enables me to understand and address such concerns during validation projects.
- How familiar are you with GMP and GDP? Answer: I am very familiar with GMP and GDP as they are essential guidelines in the life science industry that ensure the quality of products and processes during manufacturing, packaging, and distribution.
- What is your understanding of the concept of Extractables/Leachables and related analytical methods? Answer: Extractables/Leachables are chemical compounds that may migrate from a product or system into a drug product. HPLC-UV, GC-MS, and LC-MS are some of the analytical methods used to identify and quantify these compounds. Though I have limited experience in this area, I am willing to learn and develop my skills further.
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I did completed m. Sc. Microbiology
I am msc microbiology student.