About the job

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

MiGenTra Egypt is currently hiring Senior Quality Assurance Specialist .

Job Summary:

To coordinate and follow-up implementation of CAPA, follow-up SOP revision plan and change management system.

Responsibilities & Duties:

• Follow-up implementation of document control system with reference to document and record control procedure.
• Operate electronic CAPA management system and electronic change control management system and follow up implementation of SMART CAPAs till closure.
• Implement CAPA, additional controls, change control actions, annual report actions and management review actions.
• Issue quarterly reports /annual reports for non-conformities, change control, KPIs status, objectives’ actions status, training management system and revise the annual reports and annual plans for pest control and firefighting.
• Participate in data analysis for the Management Review
• Implement and follow-up the system for qualification & monitoring of outsourced activities and for suppliers’ performance evaluation according to pre-set criteria
• Report and follow-up conditional release for starting materials.
• Execute quality risk management projects, health and safety risk assessment and environmental aspects and impacts.
• Co-ordinate and gather data from different departments to be compiled in CTD format for registration purpose.
• Perform any additional tasks as requested

Qualifications:

• Bachelor degree in Pharmaceutical Sciences or Biotechnology.
• 3-6 years of experience in pharmaceutical industry.

Location: 10th of Ramadan City, Egypt.