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Ms Kenalee Patel is Heading Quality Assurance – Operations Department at Zydus-Hospira Oncology Pvt. Ltd. in Sanand, Ahmedabad is one of the leading businesses in the Pharmaceutical Manufacturers. Here I am sharing an interesting line of interaction with Mrs Kenalee Patel.
Can you tell me a little about yourself?
A:I am born and bought up in Ahmedabad. A post graduate in lifesciences with specialization in Reproductive endocrinology. I started my career in Pharma industry with Claris lifesciences (Now Baxter Inc.) as a trainee microbiologist. During my tenure of 10 years with this company, I got a chance to work in various divisions like Quality Control, Quality Assurance and Validation. Then joined Zydus-Hospira as Head Microbiology, then as Head Quality Control department and now heading the QA – Operations department.
How would you like to summarise your experience in a few lines for our readers?
A:I have more than 17 years of experience in pharmaceutical industry. My area of expertise is microbiological testing/validation and aseptic operations. I have experience with various parenteral technologies like ampoules, vials and IV bags filling for aseptic and terminally sterilized products.
What are the challenges you face in your work and how do you try to overcome them?
A: The challenge I face in work is to find actions for continuous improvements in my work area. The continuous improvements to adhere to the ever changing regulations and follow stringent compliance criteria. The only way to overcome them is to innovate the processes and activities. We, as a team, brainstorm and do GEMBA to identify improvement opportunities and find the best possible solution for the challenges we face in our day to day activities.
Could you please share us your experience using Sartorius sterility testing products?
A: I have been using Sartorius sterility testing products since many years. Sartorius is one of the
very few brands; which have been successfully and consistently delivering uniform quality of products. The range of products for sterility testing is quite extensive, to support many different types of sample.
Sartorius Sterisart®
What makes Sartorius sterility testing products different from others, from your point of view?
A: The quote from Lisa Gansky: “A brand is the voice and the product is the souvenir” stands very true for Sartorius’ sterility testing products. Vast experience of Sartorius’ in microbiology products, ensures that the products are compliant to latest regulatory guidelines and compendia. The service and technical guidance; which comes with the product is unmatched in the industry.
What are the advantages of Sartorius Sterisart® pump & Canisters as compared to others?
A: The Sterisart® pump and canisters are user friendly and compliant to latest regulations. The design is very rugged and rarely requires repair. Also, the pump are bench top and well as isolator compatible, so it provides user with flexibility of operation. The canisters are also available in variety of filter types to suit user requirement.
You have been in the industry for a very long time, what do you see has changed in the Indian Pharmaceutical industry from a USFDA?
A: Well, Indian Pharmaceutical industry has evolved a lot. The industry is adaptive to everchanging regulations and striving to improve on the quality of drugs manufactured in India. The increasing medicine export graph tells it all. The pharmaceutical manufacturers have become more cautious about adhering to the USFDA guidelines and are trying to build quality by design, instead of making post facto ammendmends.
However, considering the nos of 483s issued to Indian companies, we still need to improve on systems implementation, data integrity issues, and validation of processes.
What are the challenges one faces in Microbiological quality control?
A: According to me, the main challenge which microbiology quality control faces, is reducing the time duration of testing and adherence to the compliance level. The traditional tests like sterility and bioburden have long incubation durations.
The industry is implementing rapid microbiology techniques at a very slow pace. Also, there is less acceptance to the rapid techniques considering the fact that validating rapid methods is challenging and the regulatory approval has time and cost implications
What advice could you give to someone starting up their career?
A: To be an effective microbiologist, you must become proficient in the fundamentals. Lab techniques are very important. Aseptic techniques are not everybody’s piece of cake. So, spending quality time in QC micro labs and mastering basic techniques is important. You will be able to master the techniques only if you love working in the lab and have that “learning worm” within you. Anybody who is aspiring the career in microbiology, has immense options available to choose from. But to excel in the career, the main thing is that you should love what you are doing.
Finally, where do you find inspiration?
A: My passion for work and curiosity to learn new things, keeps me self-motivated. Every challenge I face, inspires me to do better every time.
Disclaimer: All answers/opinion shared by the interviewee are of her own. Her answers/opinion do not reflect the opinions of her current or past organizations.
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