Quality assurance Job for MSc, B Pharm, M Pharm at Lupin
Quality assurance Job for MSc, B Pharm, M Pharm at Lupin. Interested Candidates can check out the details below and Apply Online.
Job Post: Officer – Quality assurance (Biotech)
Job Location: Pune Biotech, MH, IN
Job Company: Lupin
Job Category: Quality assurance (Biotech)
Job Type: Full Time
Job Description:
- Review of the documents for production activity, Review of BPR, Protocol, SOP and
Equipment Qualification Protocols and Final reports and Monitoring of the Equipment Qualification like IQ, OQ and PQ. Review of Qualification documents for IQ, OQ and PQ done by the Vendor/Third party related to Instrument integrated with equipment - Knowledge regarding shopfloor activities like line clearance, sampling and in-process checks
- Having knowledge of QMS activity like Deviation, CAPA, Change control.
- Experience in In-process activities for drug product in Biotech / Pharmaceutical sterile facility.
Education – MSc, B Pharm, M Pharm
Total Experience – 2 – 5 Years.
Quality assurance Job for MSc, B Pharm, M Pharm at Lupin. Here are five interview questions and suggested answers for the Officer – Quality Assurance (Biotech) position at Lupin:
1. Question: Can you describe your experience in reviewing documents related
to production activities and equipment qualification protocols in a biotech or pharmaceutical setting?Answer: In my previous role, I had the responsibility of thoroughly reviewing documents such as Batch Production Records (BPR), protocols, and Standard Operating Procedures (SOPs). This involved ensuring that all documentation was complete, accurate, and compliant with regulatory standards. I also reviewed Equipment Qualification (IQ, OQ, and PQ) protocols and final reports to confirm that equipment was qualified and met the necessary standards. My attention to detail and commitment to compliance allowed me to excel in this aspect of quality assurance.
2. Question: How familiar are you with shopfloor activities in a sterile biotech or pharmaceutical facility, such as line clearance, sampling, and in-process checks?
Answer: I have a strong understanding of shopfloor activities in a sterile manufacturing environment. I am well-versed in procedures for line clearance to prevent cross-contamination and ensure product integrity. I also have experience with sampling techniques and conducting in-process checks to monitor product quality during manufacturing. These activities are essential for maintaining the highest standards of product quality and compliance in a biotech or pharmaceutical setting.
3. Question: Can you provide examples of your involvement in Quality Management System (QMS) activities like Deviation, CAPA, and Change Control in your previous roles?
Answer: In my previous roles, I actively participated in QMS activities. I was responsible for initiating and investigating deviations when deviations from established procedures occurred. I also played a key role in implementing Corrective and Preventive Actions (CAPA) to address root causes and prevent recurrence of quality issues. Additionally, I contributed to Change Control processes, assessing the impact of changes on quality and ensuring that changes were implemented smoothly while maintaining compliance with regulatory requirements.
4. Question: How would you handle in-process activities for drug products in a biotech or pharmaceutical sterile facility, ensuring compliance and product quality?
Answer: In a sterile facility, ensuring product quality during in-process activities is paramount. I would start by meticulously following established procedures for in-process checks and monitoring. Regular training and communication with the production team would be essential to maintain a high level of awareness regarding quality standards. If any deviations or issues arise, I would promptly address them through the appropriate channels, such as initiating deviation reports and CAPA processes. My goal would be to ensure that every step of the manufacturing process adheres to quality standards and regulatory requirements.
5. Question: How do you stay updated on industry regulations and best practices in the field of biotech quality assurance?
Answer: To stay updated on industry regulations and best practices, I regularly engage in continuous learning and professional development. I actively participate in industry seminars, workshops, and webinars. I also subscribe to relevant industry publications and maintain memberships in professional organizations related to biotech quality assurance. Additionally, I network with peers and colleagues to share knowledge and experiences. My commitment to staying informed ensures that I can effectively apply the latest regulatory requirements and best practices to my role in quality assurance.
These interview questions and answers should help you prepare for an interview for the Officer – Quality Assurance (Biotech) position at Lupin in Pune, Maharashtra, India.
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