Pfizer Microbiology Quality Assurance Associate Job – Apply Online

Pfizer Microbiology Quality Assurance Associate Job – Apply Online

Pfizer Microbiology Quality Assurance Associate Job – Apply Online. Pfizer is hiring candidates for an Associate – Quality Assurance vacancy. Interested and eligible applicants can check out all of the details on the same below –

Job Title: Associate – Quality Assurance

Location: India – Vizag

Job ID: 4891640

Job 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 Sr. Specialist or 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 the manufacturing practices and ensure compliance with respect to standards and approved procedures.
9. Perform daily walk throughs and report observations to the supervisors.
10. Perform equipment breakdown assessments w.r.t to product quality and patient safety with technical support/inputs from Sr. Specialist or Supervisor.
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.

Qualification: B.Pharm/M.pharm, M.Sc(Microbiology/Chemistry)

Interview Questions for Technical Round – Associate – Quality Assurance:

1. Question: Can you explain the concept of cGMP compliance and its importance in pharmaceutical manufacturing? Answer: Current Good Manufacturing Practices (cGMP) are regulations enforced by regulatory agencies to ensure the quality, safety, and efficacy of pharmaceutical products. Compliance with cGMP ensures that manufacturing processes are consistent, controlled, and adhere to quality standards. It encompasses various aspects such as facility design, equipment calibration, personnel training, and documentation. Non-compliance can lead to product recalls, regulatory actions, and compromised patient safety.

2. Question: Describe the steps you would take to assess the impact of deviations or exceptions in a manufacturing process on the final product quality. Answer: When assessing the impact of deviations or exceptions, I would first review electronic batch records (eBR) to understand the nature of the deviation. I would collaborate with senior specialists or supervisors to gather technical insights. If necessary, I would conduct a comprehensive review of the batch report and equipment audit trails. Analyzing the data and identifying potential risks to product quality, I would then communicate the findings to relevant stakeholders and propose appropriate corrective actions.

3. Question: How do you ensure that manufacturing procedures and processes align with Pfizer’s standards and regulatory requirements? Answer: To ensure alignment with Pfizer’s standards and regulatory requirements, I would regularly review and compare manufacturing policies and procedures against established standards. I would participate in equipment breakdown assessments and alarm reviews, ensuring that any deviations from standards are promptly addressed. Additionally, I would collaborate with supervisors to simplify processes and procedures, reducing downtime and enhancing operational efficiency.

4. Question: Can you provide an example of a situation where you demonstrated troubleshooting abilities in a manufacturing setting? Answer: In a previous role, we encountered an unexpected equipment malfunction during a critical manufacturing process. I quickly assessed the situation, consulted senior specialists for technical insights, and analyzed the alarm data and equipment audit trails. Through collaboration, we identified a calibration issue that was affecting the process. We immediately initiated corrective actions, recalibrated the equipment, and successfully resumed production, minimizing downtime and ensuring product quality.

5. Question: How do you ensure consistent regulatory compliance in daily manufacturing operations? Answer: Consistent regulatory compliance requires continuous vigilance and adherence to established procedures. I would conduct daily walk-throughs of the manufacturing area, observing operations and identifying any deviations from approved procedures. Any observations or non-compliance instances would be promptly reported to the supervisor. Regular monitoring of equipment alarms and assessment of trend reports would help identify potential issues early, allowing for timely intervention and corrective measures to maintain compliance.

These interview questions aim to assess the candidate’s understanding of cGMP compliance, their problem-solving skills, ability to analyze data, and their approach to maintaining regulatory standards in a quality assurance role. The provided answers offer insights into the candidate’s thought process and approach to handling various scenarios in the pharmaceutical manufacturing environment.

APPLY ONLINE

Editors Note: Pfizer Microbiology Quality Assurance Associate Job – Apply Online. Please ensure that you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest in the industry. Follow us on our social media like Twitter, Telegram, Facebook and Instagram.