Quality Assurance Specialist
4 months ago
Location: Cairo, Egypt #LI-Hybrid
About the Role:
As a Quality Assurance Specialist, you will be responsible for ensuring compliance of the Country organization with cGMP legal and Health Authority requirements and the Novartis Quality Manual and Policies.
Key Responsibilities:
- Ensure the Release of products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements and Health Authority requirements.
- Ensure that a local Quality System and Standard Operating Procedures are in place for relative GMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
- Embedding the Quality culture via Establishing a collaborative working relationship with internal and External stakeholders e.g., the Supply Chain Management (SCM), and Regulatory Affairs (RA) departments, third parties, Health Authority.
- Ensure that all aspects of the handling, manufacturing, and distribution of products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
- Ensure that all products are released to the market in accordance with the registered specifications and with local/international regulations. Ensure that an effective Change Control process is in place. Release of Medical Samples, IMP Release.
- Ensure Handling of Returned Goods.
- Ensure management of Health Authority analysis requirements.
**Commitment to Diversity & Inclusion**:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
Essential Requirements:
- Degree in Pharmaceutical Sciences.
- 2-3 years of experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs or a directly related area.
- Fluency in English and Arabic Languages.
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
**Division**
Operations
**Business Unit**
QUALITY
**Country**
Egypt
**Work Location**
Cairo
**Company/Legal Entity**
NOV PHARMA EGY
**Functional Area**
Quality
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
Yes
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