Title:  Senior Quality Compliance Officer

We are seeking a highly motivated and experienced Sr. Officer, Quality Compliance to join our team. In this role, you will be responsible for ensuring our quality management systems and compliance policies are robust and effectively implemented across all operations. You will play a crucial role in managing various quality-related systems, including change control, deviation management, CAPA, and customer complaints, to uphold the highest standards of product quality, safety, identity, purity, and quality (SISPQ).

Responsibilities:

• Develop, implement, and maintain quality management systems and compliance policies.
• Handle the change control process to manage all changes that can impact product SISPQ.
• Handle the Deviation management system and perform deviation documentation, investigation, assessment, tracking, and archiving, ensuring appropriate corrective and preventive actions are set.
• Handle the General CAPA System raised from All Quality Related Systems (Internal Audits, External Audits, Deviations, Events, Customer Complaints, Risk Assessment, or Recalls) and its follow-up to ensure the effective implementation of actions across the site.
• Handle the Customer Complaint Management System and perform its investigation, root cause identification, and ensure that appropriate corrective and preventive actions are set if needed to prevent its recurrence.
• Analyze risks to determine the amount and weight of the risk, as well as the frequency of its recurrence and the consequences of its occurrence.
• Assist in the preliminary analyses necessary for the preparation of monthly risk management reports.
• Follow up on the mitigation actions plan and implementation.
• Investigate issues related to the assessment.
• Perform training for staff on GXP & Data integrity.
• Perform annual product review for all products.

Job Specifications:

• Bachelor's degree in Pharmacy
•  +3 years of experience in quality compliance within the pharmaceutical industry
• strong knowledge of GMP/GXP regulations
• excellent analytical and problem-solving skills
• strong communication and interpersonal skills.

Job Location:

6th of October City, Giza Governorate, Egypt