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Quality Systems Specialist at GRIFOLS, S.A.
Cairo, Cairo, Egypt -
Full Time

Start Date

Immediate

Expiry Date

26 Sep, 26

Salary

0.0

Posted On

28 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Quality Management, cGMP, SOP Preparation, Deviation Procedure, CAPA System, KPI Analysis, Regulatory Compliance, Time Management, Communication, Planning, English Proficiency, Arabic Proficiency

Industry

Pharmaceutical Manufacturing

Description
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
Responsibilities
Ensure the Quality System complies with Egyptian, FDA, and EMA regulations. Responsibilities include preparing SOPs, managing Deviation and CAPA systems, and tracking Key Process Indicators.