QA - IPC Unit Head

About Minapharm

Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East with its subsidiary Rhein Minpahrm Biogenetics the premier biopharmaceutical company in Africa 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 genetically engineered proteins, with an impressive immunotherapy pipeline. Minapharm's wholly-owned Berlin-based subsidiary, ProBioGen AG, is a world-renowned contract development and manufacturing organization (CDMO), a cell line-engineering specialist, and a provider of proprietary protein and viral vector technologies to large pharma and the global biotech industry. Minapharm has established an integrated business model making it to date the only gene-to-market biopharmaceutical company in the region. Minapharm employs a collective workforce of over 1400 individuals.

Our Values:

· Diversity & Respect

· Integrity & Accountability

· Collaboration

· Leadership & Empowerment

· Innovation & Continuous Learning

Job Summary:

To lead in-process control activities for production processes in MCC and YCC areas. Assure compliance of production batch records before QA release.

Responsibilities & Duties:

• Lead in-process control team members in MCC and YCC areas, plan tasks and follow-up performance.
• Revise self-inspection reports and assure proper CAPA reporting and implementation.
• Assure compliance of production batch records before QA release.
• Review SOPs & Batch protocols related to production process before issuing.
• Review incidents/deviations related to production process and participate in investigation and assessment.
• Implement CAPA, additional controls, change control actions, annual report actions and management review actions as relevant.
• Revise data analysis, draw conclusions and suggest actions for improvement for Annual Product Quality Review.
• Ensure proper checking and monitoring of -80 ultra-deep freezers, Temperature and differential pressure of production areas.
• Reports conditional release for starting materials and tools as requested.
• Execute Quality risk management projects, health & safety risk assessment and environmental aspects & impacts as relevant.
• Perform on-site training sessions.
• Perform any additional tasks as requested.

Qualifications:

• BSc. in Pharmaceutical Science is a must
• 6-9 years of experience in pharmaceutical industry.
• Excellent Leadership Skills
• Very Good command on MS office applications
• Proficiency in English language.

Location:
10th of Ramadan City, Egypt. "Transportation Provided"