1. Responsible for Regulatory compliance for the Sterile Plant ensuring there are no major non-conformances during inspection or audits.
2. Shall have capability of independently drafting SOPs of Serile System and able to implement a Transparent Quality Strategy with scalable processes and systems that enables a decision accuracy.
3. Lead Investigations and work closely with stakeholders to arrive at proper root cause and corrective/ preventive measures to prevent recurrence.
4. Perform In-process Quality Assurance of the Sterile Area regard to Air sampling, sample monitoring, Personnel Hygiene, Particle counts etc. to remain compliant and minimize deviations.
5. Lead Media filling process validation of Aseptic manufacturing.



Lead the Sanitization Agents / Disinfectants Qualifications in Sterile manufacturing areas.
6. Responsible for WFI qualification and its validation as per regulatory requirements.
7. Lead QA in the Validation and Qualification of Sterile Processes, Equipment, and Systems.
8. Responsible for conducting Internal audits / Self Inspection for system enhancement.
9. Should have previous experience of facing external Audits of Customers / Regulatory agencies.
10. Responsible for conducting risk assessment to identify potential risks in the system/ processes and work closely with stakeholders for its mitigation plan based on the severity of the risk.

📌 AM - QA Sterile (Jhagadia)
🏢 Gulbrandsen Technologies
📍 Jhagadia