Job Scope

Manage Quality Compliance Department resources and activities

Duties and responsibilities

• Manage Quality Compliance Department resources and activities
• Approve documents generated by Quality Compliance team and any related documents generated by other departments.
• Manage external audit preparation, hosting arrangement, preparation and follow up on the audit findings responses. To have needed arrangement with other departments.
• Manage, perform and/or lead internal audits on areas as per the annual plan. To have needed arrangement with other approved internal auditors.
• Manage, perform and lead external audits on suppliers as per suppliers’ audit plan.
• Manage and monitor vendor qualifications and performance for critical vendors and compliance audits. To have needed arrangement with other approved internal auditors.
• Coordinate with the related departments to perform market recalls of any non-conforming batches due to deviation, complaint, Out of Specification. and initiate recalls documents.
• Coordinate with the related departments to handle market product complaint. Initiate and/or review needed documents as per the internal procedures, and to do the needed follow up.
• Quality metrics follow up, compilation, review, and reporting to quality management.
• Follow up on outsourced activities “Agreements”
• Follow up, review and/or approve on outsourced activities “Agreements related to under license products”
• Follow up the implementation of the Annual GMP Training Plan for all related departments.
• GMP Guidelines periodic updates follow-up including GMP trends, FDA warning letters, EU GMP non-conformance, PDA and share them with related departments
• Ensure the implementation of companywide quality management system across the board to achieve and maintain the required quality level in Dar Al-Dawa.
• Monitor the compliance with the requirements of cGLP and cGMP.
• Maintain the quality certificates from parties and authorities .
• Support in the preparation of the department budget.

Education level

Bachelor's degree in pharmacy / industrial/ chemical engineering or equivalent

Required experience

At least 10 years of experience in the pharmaceutical industry, including 7 years of administrative experience .