Quality Assurance Specialist

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.

Why Novartis: Our purpose is to reimagine medicine to improve and extend
people's lives and our vision is to become the most valued and trusted
medicines company in the world. How can we achieve this? With our people. It
is our associates that drive us each day to reach our ambitions. Be a part of
this mission and join us! Learn more here:
https://www.novartis.com/about/strategy/people-and-culture

You'll receive: You can find everything you need to know about our benefits
and rewards in the Novartis Life Handbook.
https://www.novartis.com/careers/benefits-rewards

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.

Novartis is unable to offer relocation support for this role: please only
apply if this location is accessible for you.

Join our Novartis Network: If this role is not suitable to your experience or
career goals but you wish to stay connected to hear more about Novartis and
our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
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