Regulatory Compliance:- Ensures adherence to global regulatory standards such as GMP, ISO, and FDA guidelines.
Monitors changes in regulations and updates company policies accordingly.
Quality Audits:
Conducts regular internal audits to assess compliance with quality standards.
Prepares for and facilitates external audits by regulatory agencies.
Policy Development and Implementation:
Develops and enforces quality assurance policies and procedures.
Ensures all departments adhere to these policies through training and regular updates.
Risk Management:
Identifies potential risks in processes and implements strategies to mitigate them.
Conducts root cause analysis and implements corrective and preventive actions (CAPA).
Continuous Improvement:
Promotes a culture of continuous improvement within the organization.
Implements quality improvement projects and monitors their progress and impact.
Documentation and Reporting:
Maintains comprehensive records of quality assurance activities and audit findings.
Prepares detailed reports for senior management and regulatory bodies.
-Travelling to own factory, contract manufacturing sites or LL sites required.
Should have minimum 2 years of experience in Tablets. Capsules, Injectables quality assurance in plant.