Quality Systems Specialist At Grifols Egypt Plasma
Full Job Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
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.
ENVIRONMENT
Internal: Plasma Quality Assurance, Quality System Manager, Administration & Services divisions, and Grifols Egypt for Plasma Derivatives plasma general management.
External: In absence of the Quality System Manager, Health Authorities, Government authorities and auditors.
KEY RESPONSIBILITIES
Prepare and review SOP’s 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.
Location: EMEA : Egypt : Egypt:EGTOLIP – Tolip El Narges-New Cairo