Quality Audits Specialist

JOB OBJECTIVE

To evaluate critical suppliers according to the established procedures based on Audits performance result and KPIs (Key Process Indicators) established for measuring level of cGMP compliance of product as well as services received.

KEY RESPONSIBILITIES

• To edit SOPs related to suppliers qualifications following the guidelines established according to Egyptian regulations and the guidelines established according to cGMP requirements.
• Manage and oversee a system of a global qualification process of suppliers, considering Key Process Indicators (KPI), and audit performance results, that will ensure the correct evolvement of suppliers
• To perform supplier evaluations and root cause investigations to implement corrective actions on raw materials and contracted services.
• To provide Supplier Qualification Manager / Quality Audits Senior Manager information related to the results of evaluation made together with Audits Area about the performance of Suppliers according to establish system of evaluation.
• Develop, issue, review, evaluate, and follow up on all supplier corrective action requests, as appropriate. Participate in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements.
• Participate in and support Regulatory inspections received by Health Authorities.
• Participate in internal audits program as auditor qualified.
• Act as a liaison to suppliers regarding development and maintenance of Quality Agreements.
• Work closely with purchasing managers, end-users, and suppliers to resolve compliance issues and problems as part of risk management activities.

ACADEMIC EXPERIENCE REQUIRED

Bachelor s Degree in Health-related Sciences.

Knowledge of Quality Management.

Knowledge of cGMP requirements preferred.

PROFESSIONAL EXPERIENCE REQUIRED

Typically requires a minimum of 2 years of related experience in GMP Suppliers Qualification program within a Pharmaceutical Company preferred.

LANGUAGES

Written and spoken English and Arabic.