Quality Risk Management Specialist

About Minapharm:

Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering. Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline. Together with its wholly-owned Berlin-based subsidiary, ProBioGen AG - a world-leading CDMO, Minapharm has established an integrated business model making it the only gene-to-market company in the region. Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, has incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.

Our Values:

Diversity & Respect

Integrity & Accountability

Collaboration

Leadership & Empowerment

Innovation & Continuous Learning

Job Summary:

Handle the Quality risk management projects & risk teams to properly identify, assess risk, and set treatment strategies and mitigation plans then report to the CAPA & Risk Management Manager for review & approval.

Report the overall status & the effectiveness of the quality risk management (QRM) process.

Duties:

• Establish a risk identification and assessment process within departments that covers quality and business risk categories.
• Set risk treatment strategies and governance for all significant risks till reaching acceptable and controllable level of risk
• Coordinate risk governance teams representing different departments within the company with the required qualifications, skills and appropriate competencies in performing their tasks.
• Maintain and follow up the revision of issued risk management projects according to relevant SOPs and risk management log.
• Maintain the register of significant risks; ensure appropriate escalation of top risks and feedback mitigation progress to appropriate level of management.
• Document risk management decisions at risk governance meetings and report the overall status of risk identification and mitigation plans, impact on level of risks and effectiveness of the risk management process to the company's governance system.
• Execute the Quality risk management projects to comply with Licensors as per updated new cGMP requirements.
• Execute the Quality Risk management projects required for all relevant Change control requests (new requirement).
• Participate in European GMP Project, ISO Re-Certification projects & any other Quality improvement projects to comply with cGMP guidelines.
• Coordinate Quality risk management projects related to SWOT analysis as per ISO requirement.
• Arrange Quality risk management projects meetings.
• Report the feedback reports, Overall status & effectiveness of the QRM process to the Manager.
• Record deviations and changes and participates in investigation and assessment.

Job Requirements:

Experience: 3 - 3 years of Experience

Education: Bachelor's degree in Pharmaceutical Science.

. Training : cGMP Training