Africa QA Manager, Health

• Ensure quality governance and quality planning within Africa Global Health, through the implementation of quality systems and processes and the annual Quality Plan.


• Lead the QA function thereby ensuring that all processes and procedures, tasks, responsibilities and projects are in compliance with all pharmaceutical laws, the Sandoz Quality Manual and Policies , Africa Global Health strategies as well as Industry Best Practices


• Prevent significant quality issues or regulatory non-compliance which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the company as well as the reputation


• Ensure implementation and maintenance of Quality System and Standard Operating Procedures within Africa Global Health, in order to drive compliance of all cGXP related processes and tasks with local/international regula-tory requirements and the Sandoz Quality Manual.


• Ensure quality governance and quality planning for Africa Global Health, through the establishment and implementation of the annual Quality Plan, appropriate Key Quality Indicators, and Quality Risk Assessments.


• Ensure review and approval of artworks where appropriate


• Ensure efficient information flow and effective communication of all relevant quality matters within Global Health, to the Global QA organization and vice-versa including but not limited to issue escalation.


• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that support on all quality related matters is provided Global Health stakeholders.


• Ensure that coordinated contact is maintained with the local Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and QA centralized support service like Export Market Hub.


• Provide quality oversight and direction to third parties and ensure that they are qualified to perform their activities in compliance with Sandoz Quality Standards.


• Ensure that all drug products are released in accordance with the registered specifications and are released to the market in accordance with local/international regulations and ensure that respective Change Control procedure are implemented.


• Ensure management of external inspections, complaints, recalls, counterfeits and product tampering according to the Sandoz Quality Manual and local written procedures.


• Ensure implementation of adequate training within the area of responsibility for all GXP activities by defining, planning and supporting training activities

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment
and diverse teams representative of the patients and communities we serve.
Minimum requirements
* Degree in Pharmacy, Life Sciences or related fields
* Where required, must be eligible to act as Qualified Person under local legislative requirements
* Min. ‎5 years' experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, pro-duction, distribution or a directly related area.
* Where required by the local regulation, Registered Pharmacist eligibility is an advantage.
* Strong IT Background
* Influencing skills - Autonomy / Well organized / Self-driven - Good communication skills / Training skills
* Strong organization awareness (e.g. interrelationship of departments, business priorities), including experience working with cross-functionally and in global teams
Division
SANDOZ
Business Unit
Commercial OPS SIR SZ
Country
Egypt
Work Location
Cairo
Company/Legal Entity
HEXAL EGY
Alternative Country ‎1
Utd.Arab Emir.
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No