QC 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
MiGenTra Egypt is currently hiring the following position "Biotechnology QC Specialist - Stability"
Location: 10th of Ramadan City, Egypt
Job Summary:
Perform QC analytical testing of stability samples of intermediates, final bulks and finished products of MiGenTra Egypt, mAB areas, and all related tasks, aiming at high quality production to achieve the company’s goals.
Duties:
1.Perform QC analytical testing of stability samples of intermediates, final bulks and finished products of MiGenTra Egypt, mAB areas.
2.Comply with the annual objective of departments, Company’s policy and the predetermined KPIs.
3.Efficiently operate all equipment within the QC, including data handling, results interpretation & reporting. Ensure the continuous suitability of equipment and its readiness for good laboratory practice, comply with the GLP and IMS requirements, record all processes within the good documentation practice.
4. Issue new SOPs and revise approved SOP according to revision plan and current needs, initiate change controls according to instructions.
5. Notify timely supervisor, record and report incidents and deviations, participate in investigations and assessments, define root cause and set SMART corrective and preventive actions for audit findings, incidents & deviations and Implement CAPA.
6.Contribute to quality risk management projects, support continuous process improvements, report and support assessing environmental hazard aspects and impacts, report and support assessing health and safety risk assessment.
7.Strongly cooperate with other units (for instance stability mAB unit), and other departments (for instance mammalian and yeast upstream and downstream, buffer preparation, QA, warehouse, engineering and R&D) aiming at smooth and efficient process flow.
8. Perform any additional tasks as requested in the field of employment.
Job Requirements:
Bachelor’s degree in Biotechnology or Pharmaceutical Science.
From 0 – 2 years of experience in relevant field.
Excellent in English Language.