Key Responsibilities:

1. Establish internal and external audit plans and execute such plans and follow-ups thus meeting all Delta internal regulatory requirements to ensure compliance to quality systems on site.
2. Evaluate current vendors, service providers and potential new vendors in the areas of productivity capacity and performance.
3. Carryout risk analysis of vendors and formulate action plans where need.
4. Perform internal audits for the maintenance and continuous improvement of the management system and compliance to regulatory requirements.
5. Create and maintain internal auditing schedule and conduct internal audits.
6. Create and maintain External auditing schedule and conduct External audits.
7. Handling Quality System Via Change Control to make sure steps quality if taken any change including (Assessment- Follow up – Tracking Required Actions till implantations).
8. Performs review, approval and tracking of cGMP processes, procedures, assays, documents, and records, including Non-conformances, CAPAs, Change Control.
9. Evaluate audit findings and implement appropriate corrective actions.
10. Follow up the implemented and corrective actions from NCR points.
11. Participate in the establishment, and implementation of new standards and processes.

Qualifications & Skills:

1. Bachelor’s degree in pharmaceuticals Science or science
2. 1-3 years of experience
3. Excel – PowerPoint- Most office software- FDA- EU- GMP operations- compliance- Microsoft word
4. Work ethic- Critical thinking- Adaptability – Creativity –Teamwork – conflict resolution- Decision making- Attitude- Empathy