KEY RESPONSIBILITIES AND DUTIES:

Responsible for routine external manufacturing activities:

Preparation of Quality agreements with manufacturing subcontractors performing activities on our behalf and follow up of its approval.

Following up CAPA implementation of external audits.

Frequent visits to subcontractors to follow up the process and to ensure the compliance to cGMP, Our requirements when applicable and with local regulations.

Participate in suppliers & subcontractors audits:

Preparation of annual plan for suppliers & subcontractors on yearly basis.

Participate in external audits for suppliers & subcontractors.

Responsible for routine Internal Quality Inspection system

Develop and implement quality assurance policies and procedures

Plan and conduct quality audits and inspections

Monitor and analyze quality performance and trends using statistical methods and tools

Identify and resolve quality issues and non-conformities

Coordinate and supervise quality testing activities

Train and mentor quality assurance staff and other employees on quality standards and best practices

Prepare and present quality reports and documentation

Management of Product Technical Complaints:

Responsible for investigating, root cause identification and action plan follow up for all Customer Complaints.

Communication and follow up customer complaint investigation related for toll out products 

Responsible for accreditation & internal audit for ISO 9001:2015 System

Participate in Quality Risk Management:

Participate in identifying, analyzing, evaluating, controlling, communicating, and reviewing potential or identified risks related to quality and GxP compliance in alignment with global quality documents.

Work as risk assessments facilitator for the assigned risks.

Working ERP System Activities:

Approve finished/ semi-finished product recipes on ERP system.

Create/update Quality Info Records for materials on ERP system.

Create Inspection Plan for materials on ERP system.