Quality Systems Specialist (SAP/DI)

JOB OBJECTIVE

Responsible of ensuring that Quality System in place is in compliance with Egyptian Regulation and in accordance to FDA and EMA Regulation, staying abreast of current and new regulations in order to analyze their impact on Quality system established.

KEY RESPONSIBILITIES

• Prepare and review SOPs related to Quality Systems following the guidelines established according to Egyptian regulations and the guidelines established according to cGMP requirements.
• Establish a defined Deviation procedure and CAPA system, involving appropriate stakeholders for investigation and closure.
• Compile all the information related to the different processes referred to Key Process indicators established for the Quality system.

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 Quality Systems within a Pharmaceutical Company preferred.

COMPUTING SKILLS

Proficiency in Computers

PERSONAL SKILLS

• Organized and able to manage time effectively.
• Ability to work within a highly regulated, labor intensive environment.
• Ability to understand, explain, follow, and enforce SOPs and protocols
• Ability to plan, communicate and execute activities for the improvement of overall operations.

LANGUAGES

Written and spoken English and Arabic