Process Validation & Qualification expert

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:

Coordinate, implement and report process validation inside production departments to verify the continuous capability of production processes to comply with local authorities, WHO, EU regulations and fulfill cGMP guidelines.

Duties & responsibilities:

1. Follow up the monthly plan and communicate with production departments to perform the required validation tasks.
2. Create formulas and recipes on ERP.
3. Prepare validation protocol
4. Witness the different processes of manufacturing, withdraw samples and send it to quality control department to analyze the samples.
5. Withdraw cleaning validation samples from production machines to ensure their compliance with cGMP.
6. Issue validation report with outcomes of the validation and statistical process analysis.
7. Share in qualification activities, thermal validation, mapping and CSV
8. Prepare relevant SOPs, procedures.
9. Batch record review to ensure compliance with cGMP.
10. Deviation reporting & set CAPAs
11. Create & Review qualification reports.
12. Carry out any additional job-related tasks that are assigned.

Qualifications:

• 6-9 years of relevant experience in pharmaceutical industry.
• B.SC of pharmacy or engineering

Acquired trainings in:

• cGMP
• Sterile & aseptic techniques
• Six Sigma.
• QRM.

Must have knowledge:

• Intermediate Knowledge of the general rules of good manufacturing practice,
• Intermediate Knowledge of Six Sigma.
• Background on solid & sterile manufacturing techniques.
• Awareness of TQM.