Quality Assurance Specialist

4 days ago

Cairo, Cairo, Egypt MiGenTra Egypt Full time 120,000 - 240,000 per year

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

Responsibilities & Duties:

  • Ensure that Document Control System / Change control systems are properly implemented
  • Ensure adherence to all relevant rules and regulations
  • Issue new relevant SOPs and revise the approved SOP according to revision plan.
  • Execute quality risk management projects.
  • Prepare protocol, execute qualification protocols and report outcomes for Equipment / Utilities qualification.
  • Report outcomes of process validation and cleaning validation activities.
  • Report outcomes of production area qualification and steam sterilization qualification activities.
  • Prepare protocols, execute and report thermal mapping activities

Qualifications:

· Specialist: From 0 to 3 years of related experience.

. Senior Specialist: From 3-6 years of experience.

· Bachelor degree in pharmaceutical science.

· Ability to work effectively with diverse populations.

· Ability to persuade and influence others.

· High attention to detail and excellent analytical skills

Location:
10th of Ramadan City, Egypt

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