385997BR

Quality Assurance Specialist.

Egypt
About the role

Location: Cairo, Egypt #LI-Hybrid

About the Role:

As a Quality Assurance Specialist you will be responsible for the technical
and market release (QP) after assuring that appropriate practices, systems and
processes are in place working closely with the Quality Control (QC) teams, by
executing QA oversight; assuring that all QC areas and relevant activities are
following the requirements of ISO9001, HAs, cGMP, GLP and Novartis Quality
Management System (QMS), and that quality strategy is implemented with a
continuous drive to improve products, practices and processes quality.

This role reports directly into the QA Operations Head and will work hand in
hand with the Quality Teams.

Key Responsibilities:

• Quality records QA and final QA decision maker for all quality records including deviations and release OOS/OOE records related to FGs, stability and different QC lab areas.


• Review/ approval of QC GxP documents and records.


• Delegated release person from site Quality head (i.e. QP) to ensure QC results completion and being reviewed by qualified QC reviewer and for "Duty of care check".


• Execution of planned and unplanned QA oversight activities in QC and Microbiology areas to ensure the ongoing compliance status, that QMS requirements are followed and in place, to identify areas of improvement, agree upon needed actions (e.g. CAPAs) based on outcomes and follow-up appropriate closure of the outcomes.


• A certified investigator that supports in QA investigations of quality records (e.g. Deviations, complaints, etc.) and QC OOS/OOE records.


• Overseeing reference standards handling process and approving the in-house qualification reports and certificates of analysis, and releasing of the reference standard batches for use.


• Supports in all QC operations QA tasks related to AS&T (Stability, Validation, and Qualification) whenever requested or delegated.


• Perform all site-support tasks whenever requested.


• Deputize QC/QA Operations Expert (QC, Microbiology & Release QA) whenever delegated.

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.
Role Requirements
Essential Requirements:

• Bachelor's degree in Pharmaceutical Science or a relevant discipline.


• ‎0-‎2 years of experience in a relevant position.


• 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
Work Location
Cairo
Company/Legal Entity
NOV PHARMA EGY
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
Yes
Early Talent
Yes