Quality as
surance vacancy at Pfizer for candidates B. Pharma / M. Pharma / M.Sc candidates. Pfizer opening for BPharma MPharma MSc jobs at Vizag. Please go through the details for BPharma MPharma MSc job and apply online.Position – Associate – Quality Assurance
Location – Vizag, India
Responsibilities –
1. Responsible for ensuring operating state of cGMP compliance in solution/emulsion preparation, vial/ampoule washing, depyrogenation, filling and capping operations.
2. Maintain regulatory compliance in accordance with cGMP practices.
3. Ensure manufacturing policies and procedures conform to Pfizer standards.
4. Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from supervisor.
5. Review of batch reports and equipment audit trails.
6. Perform EMS alarm impact assessments and monthly trend reports.
7. Ensure start-up and in-process activities performed as per batch record and SOP compliance.
8. Monitor and adherence manufacturing practices with respective standards and approved procedures.
9. Perform daily walk throughs and report observations to the supervisors and ensure appropriate closer of those incidents.
10. Perform equipment breakdown assessments w.r.t to product quality and patient safety independently.
11. Review and approval of equipment alarms and review of alarm trends.
12. Report any non-compliance to the supervisor.
13. Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
14. Identify gaps and involve in process and procedure simplification, thereby reduce downtime and increase the efficiency.
15. Experience in handling regulatory, corporate and internal auditors / inspectors.
16. Responsible for assisting manufacturing investigators w.r.t collection of data, information and technical support and may perform in conducting investigations.
Qualification and experience-
- B. Pharma / M. Pharma / M.Sc.
- 2-4 years’ experience in Manufacturing Quality Assurance / Quality Assurance/ Production of a pharmaceuticals manufacturing facility.
Attaching interview questions and answers that are expected for BPharma MPharma MSc job. It will help you to prepare well for the interview. All the best for your interview!!!
Question: How would you ensure cGMP compliance in solution/emulsion preparation and filling operations?
Answer: Ensuring cGMP compliance in solution/emulsion preparation and filling operations requires strict adherence to standard operating procedures (SOPs) and Pfizer’s manufacturing policies. I would meticulously review and follow the established procedures for each step of the process. Additionally, I would conduct regular walk-throughs, monitoring the manufacturing practices, and promptly reporting any observations or incidents to my supervisors for appropriate action. This proactive approach would help maintain the required operating state of cGMP compliance.
Question: Can you describe your experience in handling regulatory audits and interactions with auditors/inspectors?
Answer: I have experience in handling regulatory, corporate, and internal auditors/inspectors in my previous roles. During these audits, I collaborated with cross-functional teams to gather the necessary data and information. I ensured that all relevant documents were readily accessible and compliant with regulations. As part of the process, I also addressed any queries or concerns raised by the auditors professionally and confidently, reflecting a thorough understanding of our manufacturing practices and quality assurance procedures.
Question: How do you approach troubleshooting in the manufacturing area to maintain product quality and patient safety?
Answer: Troubleshooting in the manufacturing area requires a systematic approach. First, I would analyze the nature of the issue and its potential impact on product quality and patient safety. Next, I would consult relevant technical support and gather necessary data to identify the root cause of the problem. Once the cause is determined, I would develop and implement appropriate solutions to resolve the issue promptly. My ability to troubleshoot effectively ensures that manufacturing processes run smoothly, minimizing downtime, and upholding high-quality standards.
Question: How do you stay updated with the latest cGMP practices and regulations?
Answer: As a pharmaceutical professional, I understand the importance of staying up-to-date with the latest cGMP practices and regulations. I regularly participate in training sessions, workshops, and seminars conducted by industry experts and regulatory authorities. Additionally, I actively engage with professional networks and subscribe to relevant publications to keep myself informed about any updates or changes in the regulatory landscape. This continuous learning approach helps me maintain compliance and ensures that our manufacturing practices align with current industry standards.
Question: Can you provide an example of a process or procedure simplification you initiated in your previous role to improve efficiency?
Answer: In my previous role, I identified a process bottleneck in the equipment breakdown assessment. To address this, I proposed a streamlined approach that involved creating standardized checklists for equipment breakdown evaluations. This not only reduced the time required for assessments but also improved the consistency and accuracy of our evaluations. The simplified procedure allowed us to respond promptly to equipment breakdowns, ensuring minimal impact on product quality and patient safety while increasing overall operational efficiency.
