Validation section Head

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, have 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.

Minapharm Group of Pharmaceutical Companies employ a collective workforce with more than 1400 individuals & continues to expand their workforce with Talented Human Capital.

Our Core Values:

• Diversity & Respect
• Integrity & Accountability
• Collaboration
• Leadership & Empowerment
• Innovation & Continuous Learning

Job Mission:

To manage, supervise, coordinate, and review reports of all processes & computer system validation inside production departments to verify the continuous capability of production processes to comply with local authorities, WHO and EU regulations and fulfil cGMP guidelines.

Duties:

1. Receive the production plan to set the process validation monthly plan.
2. Provide Technical assessment to determine the need for process validation activities in production in case of deviations &, changes (i.e. new material supplier’s .etc.).
3. Perform and supervise computerized system validation in order to verify the system's performance as per the intended use.
4. Review qualification protocols and reports to comply with cGMP standards.
5. Establish risk assessment studies relevant to the validation documentation.
6. Review validation protocols and reports to comply with cGMP standards.
7. Supervise process validation activities in production departments.
8. Coordinate validation activities cross-functionally in the quality and production departments.
9. Assist in performing investigations and optimization for non-compliant troubleshooting in production areas.
10. Collaborate with (MOH, licensors,,…etc.) on regulatory and compliance responses related to validation / qualification issues.
11. Update validation documents regularly according to cGMP regulation.
12. Perform and review the validation part of CTD files for Minapharm products.
13. Calculate quality KPIs for validation.
14. Review relevant SOPs, procedures and plans.
15. Create formulas and recipes on the Oracle system.
16. Conduct on-site staff training sessions as required.
17. Carry out any additional job-related tasks that are assigned.

Experience:

• More than 9 years.

Education:

• B.SC of Pharmaceutical Sciences.

Training:

• cGMP.
• Process validation.
• Computer system validation.

Knowledge:

• Advanced Knowledge of the cGMP.
• Intermediate Knowledge of Six Sigma.
• Advanced Knowledge of Process validation
• Advanced Knowledge of Computer system validation.
• Awareness of TQM.

Abilities:

• Ability to plan, prioritize and manage projects.
• Ability to communicate effectively with different levels.
• Ability to measure performance and effectiveness of different processes.
• Ability to take control and exercise leadership, give direction and take responsibility.
• Ability to coach others and delegate tasks.
• Computer literate.
• Proficient in English Language.

Behavioral competencies:

• Leadership skills.
• Ownership & initiatives.
• Coaching and developing others.
• Planning & organizing skills.
• Strong presentation & communication skills.
• Able to manage changes.
• Relating and networking