1. How was your experience as a guest lecturer at Biocon Academy?

• It was an exciting to share my experience and knowledge about Quality and its varied elements with the budding scientists who will be launching their careers soon.

2. What is the role of QC in the biopharmaceutical industry?

• I believe the role of QC is to ensure the quality of the product at each stage of the manufacturing process till it finally reaches the patients.

3. How do companies prepare for the USFDA audit in QC?

• In the current regulatory scenario, companies are expected to be ready at all-time audit. Biocon Biologics Quality team ensures the following 24*7
• Procedures are meeting the regulatory requirements
• Practices are in line with the approved procedures
• Transparency in the execution as well as the presentation of data
• Ensuring the obtained data is analyzed appropriately and actions are taken at the right time

4. How are the QC failures resolved?

• I think these are addressed defined procedures of investigation which include root cause analysis tools such as fault tree analysis, Ishikawa tools, 5 Why analysis, etc. All the investigation needs to be based on scientific rationale. It is important that the Quality failures are handled by the Subject Matter Experts with experience on the relevant topics. These investigations are followed by ensuring robust Corrective & Preventive Action (CAPA) plans. We also ensure that we have a robust validation of processes and the analytical methods to avoid any failure at the beginning of any process.

5. What is the future of a QC analyst in the Indian and global pharmaceutical/biopharmaceutical industry?

• I believe, considering India as one of the growing health care service providers, QC analysts will certainly have very rewarding & exciting career opportunities.

6. What are the essential traits of a QC analyst/inspector?

• Have subject matter expertise/Technical knowledge
• Patient-Centric thought process
• Problem-solving skills
• Teamwork
• Get the basics right, each & every time
• Right first time & and an eye for the details
• Work integrity

7. How does QMS play an important role in a biopharma company?

• Quality Management System (QMS) is the backbone of the biopharma company. Any failures, deviations, and changes are handled through the QMS. QMS system provides the overall health status of the organizational growth as well as the culture.

8. How do you troubleshoot a problem through CAPA or fishbone analysis?

• Root cause analysis is performed through the appropriate investigation tool to identify the actual cause. One cause is attributed to the appropriate corrective and preventive action (CAPA) plans those are initiated to prevent the re-occurrence of the problem.

9. How do you think Biocon Biologics is making a difference among its Patients, People, Partner & Business in global health through QMS?

• Patients – By Delivering affordable access transforming patient lives
• People- Co-creating a culture of Constant Innovation
• Partner- By Delivering innovative and inclusive healthcare solutions
• Business- Positioning as Global Leader in Biologics

10. What are your thoughts on the Biocon Academy’s programs? How beneficial are these programs for biotech students?

• Biocon Academy is providing hands-on experience and exposure to the students on Pharma industry-oriented modules along with excellent placement opportunities with global companies. The programs developed by the academy are very beneficial for the industry as well. The students who have joined Biocon Biologics from academy are found to very professional in their approach & doing very well across all Biocon Biologics locations.

11. One advice for the students seeking a career in Quality?

• A pharmaceutical career is a noble profession where the students will serve patients. Students must be empathetic to the patient’s lives. Their work should also focus on patient-centricity first, which eventually will help the organization in maintaining a high standard of quality.

Profile:

Mr Pravin Kulkarni delivers guest lectures at Biocon Academy on a regular basis. He has over 20 years of performance driven experience in various areas of the pharmaceutical industry with companies such as Mylan , Emcure, Cipla. He is Familiar with various Quality Assurance processes and documentation system, SOP’s, cGMP, GLP, and cGCP. He is currently heading QCMB and QCAT at Biocon Biologics.