Senior Information Technology Auditor

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:

Manage all validation activities related to introduction of new products, technical transfer, validation of processes (including process performance qualification, validation of sterilization processes & aseptic process simulation) and gowning qualification.

Responsibilities:

1. Prepares process validation (including process performance qualification, validation of sterilization processes & aseptic process simulation), cleaning validation & gowning qualification procedures, master plans and protocols.
2. Prepare annual plans for process validation (including process performance qualification, validation of sterilization processes & aseptic process simulation), cleaning validation & gowning qualification with coordination with different departments (eg: strategic operations, supply chain, production, engineering, QC … etc).
3. Issue purchase requests for all department requirements required to execute process and cleaning validation activities and ensure their availability on time.
4. Coordinate with different departments (eg: production, engineering, QC … etc) the execution of process validation (including process performance qualification, validation of sterilization processes & aseptic process simulation), cleaning validation & gowning qualification protocols as per approved annual plans.
5. Handles any deviations or changes related to process validation (including process performance qualification, validation of sterilization processes & aseptic process simulation), cleaning validation & gowning qualification.
6. Periodically evaluate status of qualification and validation of process validation (including process performance qualification, validation of sterilization processes & aseptic process simulation), cleaning validation & gowning qualification and prepares periodic reports.
7. Participate in different multidisciplinary teams and relevant activities as required.
8. Lead, coach & develop subordinates.
9. Perform other relevant tasks as required.

Qualifications:

Experience:

• 9 - 12 years in pharmaceutical industry including experience in process validation / cleaning validation activities in sterile manufacturing.

Education:

• BSc in Pharmaceutical sciences or Science .

Training:

• WHO & EU GMP process validation and cleaning validation guidelines.
• Sterilization techniques and validation of sterilization processes.
• Aseptic processing & aseptic process simulation.
• Production technologies.

Knowledge:

• EDA, WHO, ICH, PIC/S & EU guidelines and/or regulations related to validation.