Plasma Quality Assurance Senior Manager

7 months ago

مصر, Egypt 00E1 - Grifols Egypt Plasma Der Full time

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**:

- Design, implement, and improve company Quality standards following Egyptian laws and EDA Regulation and in accordance to FDA and EMA Regulation. Analyse data to findareas for improvement, following applicable regulation and in compliance with Product licenses approved by Health Competent Authorities
- To follow up periodical assessment of Quality system through different KPI’s established.

**Environment**:

- Monitor QA aspects of Plasma Collection, warehousing, testing, and shipping practices in
- Donor Centres to ensure compliance with Egyptian Regulation and international standards.
- Ensure implementation of Quality systems as Documentation System, Deviation, and CAPA management systems.
- Ensure the implementation of a Risk Management system among GxP areas.
- Define KPIs and ensure compliance, including management and reporting.
- Technical Support of Regional Quality Manager to ensure that Donors Centres operate in compliance with Quality standards.
- Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.
- Perform assigned tasks by direct Manager.

**Academic experience required**:

- Bachelor’s degree in health-related Sciences.
- Post-graduated in Quality Management preferably.
- Knowledge in cGMP.

**Professional experience required**:

- typically requires a minimum of 10 years of related experience in Blood transfusion services or Pharma background preferred, under environments of Good Manufacturing Practices.

**Computing skills**:

- Proficiency in computer, MS Office knowledge

**Personal skills**:

- Ability to work within a highly regulated, labor intensive environment.
- Effective organizational and planning skills with ability to meeting deadlines required.
- Analytical and enquiring mind with the ability to interpret data and facts.
- Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to groups.
- Manage, coach, and develop team that meets agreed objectives, and which delivers best practice results, added value and continuous improvements.

**Languages**:

- Written and spoken fluent English and Arabic.

LI-MB1

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

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