CAPA Specialist At Minapharm Pharmaceuticals
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 CAPA management process through handling non-conformities, root cause analysis & investigations, CAPAs agreement & effective closure for GMP Internal & external audits.
Duties:
1. Prepare CAPAs table for GMP internal Audit and external audits nonconformities for all concerned departments.
2. Perform CAPAs assessment and send the results of CAPAs assessment to all concerned departments.
3. Support the owners performs root cause analysis process and investigation to reach agreed acceptable SMART CAPAs with due dates.
4. Hold CAPAs meeting if there is no satisfactory reply and/or need cross functional team to find proper action for solving the nonconformities.
5. Cooperate with concerned departments to demonstrate CAPAs closure based on assessment of the objective evidences received and measures CAPAs effectiveness for closed CAPAs
6. Manage risk based CAPAs extension and change.
7. Manage electronic and/or manual CAPA management system and follow up implementation of SMART CAPAs till closure & send periodic reminders for the concerned persons
8. Prepare quarterly KPIs for CAPAs for each department, and report in management review meeting.
9. Measure CAPAs effectiveness for closed CAPAs.
10. Report the overall status of CAPA management process through its all stages to CAPA & Risk management expert.
11. Record deviations and changes and participate in investigation and assessment
12. Execute Quality risk management projects when needed.
Job Requirements:
· Experience: 0 - 2 years of Experience
· Education: Bachelor’s degree in Pharmaceutical Science.
Training : cGMP Training