Dr. Kartikey Swami]

• Managed and motivated employees to be productive and engaged in work.
• Accomplished multiple tasks within established timeframes.
• Maximized performance by monitoring daily activities and mentoring team members.
• Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
• Overall ISO QMS implementation
• Vendor and Supplier dealing
• Handling of CAPA and customer complaits.

Overall QMS responsibility

Assisting Head-Quality in Quality Management implementation

Lead Auditee

• Supervised day-to-day operations to meet performance, quality and service expectations.
• Improved customer satisfaction by addressing and resolving complaints promptly.
• Assisted Head Quality Assurance in implementation of QA
• Performing Investigations
• Approval of deviations, OOS, OOT change management and CAPA
• All QA activities as mentioned in ICH Q7

QA of QC

Investigations

RCA

Document Integrity Assurance as per FDA

Complete handing of QA functions

QA functions

QC and Analytical R&D functions