Executive – Quality Assurance & Regulatory Affairs

  • Full Time
  • Mumbai

A Globally Renowned Healthcare Organization

# Quality Management, # Quality Control # Regulatory Affairs

Regulatory Affairs

1.       Preparation of regulatory documents e/g. DMF, PE Dossier, etc. with compilation of dossier, review regulatory application & submission of all required applications pertaining to company with full responsibility & accountability.

2.       Understanding & interpretation of law & the local regulatory requirements and implementing the same in India for ensuring compliance of company’s Products.

3.       Responsibility for close coordination & regular follow-up with the Regulatory Authority for timely obtaining of all approvals.

4.       Coordination with global regulatory team, local marketing & other functions, required for regulatory submissions with regulatory authorities.

5.       Responsible for regulatory activity with compliance and maintain reputation of the organization before authorities.

6.       Respecting & following all SOP / system implemented within the department and organization.

Quality Assurance

1.       To create and maintain processes/procedures for ensuring compliance to global standards/guidelines and local requirements.

2.       To implement product labeling activity adhering to local regulatory guideline and global quality standards.

3.       To implement standard and documented processes required for supply chain and local distributor quality.

4.       To coordinate with warehouses, transport partners for adherence to quality guideline, validations, risk management and help in audit of warehouse & implement continuous improvement in process and system.

5.       To assist quality head to lead, set and improvise quality management system of organization.

6.       To train the employees on the global quality aspects monitors the process to ensure product quality as per the standards.

7.       To help in implementation of Post market surveillance standard, and responsible for Risk assessment and CAPA at affiliate level.

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