Africa QA Manager, Health

4 days ago


مصر, Egypt Sandoz Full time

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



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