Quality Systems Specialist (Egypt)

؜ - ؜مصر ؜ -

تفاصيل الوظيفة

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.
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LI-LS1_


Location: EMEA : Egypt : Egypt : EGTOLIP - Tolip El Narges-New
Cairo


Learn more about Grifols

ملخص الوظيفة

  • المُعلن : Grifols
  • تاريخ الإعلان : 18/10/2022
  • نوع العمل : -
  • مستوى الخبرة : -
  • المستوى التعليمي : -
  • الراتب : -
  • الهاتف : -

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Language: English