Quality Assurance Specialist (Compliance / In Process control / Internal Audit)

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 hiring several positions in the QA Department.

Responsibilities & Duties for QA Compliance Specialist:

• Participate in update procedures relevant to pharmaceutical quality system compliance, gap analysis, internal audits, supplier audits, quality risk management and GMP training.
• Participate in annual internal audit schedule, prepare internal audit reports, send approved internal audit reports to owners, agree with owners on SMART CAPAs, follow up closure of CAPA and evaluate CAPA effectiveness and quarterly report status of internal audit QKPIs.
• Participate in audits of supplier / contractor / contract acceptors, prepare audit reports, send approved audit reports to supplier / contractor / contract acceptors, agree with them on SMART CAPAs, follow up closure of CAPA and evaluate CAPA effectiveness and quarterly report status of supplier / contractor / contract acceptors audit QKPIs.
• Ensure that all employees (permanent, temporary) and contractor / visitors receive required GMP training before they independently certified to perform their tasks independently.
• Prepares a register of qualified trainers, participate in preparation of training programs, participate in evaluation of training effectiveness and quarterly report status of GMP training QKPIs.
• Participate in all quality risk management activities with cross-functional teams of SMEs. Follow-up closure of all actions required to reduce risks to an acceptable level and evaluate effectiveness of these actions through after action risk review. Quarterly report status of quality risk management QKPIs.
• Work with cross-functional team to develop and maintain site contamination control strategy. Prepare a quarter report indicating status of contamination control strategy and its effectiveness in controlling contamination and cross-contamination risks and recommendations for improvement.
• Perform PQR data collection, review, analysis and reporting for all manufactured products. Set recommended actions and required SMART CAPA with follow up closure of CAPA and evaluate CAPA effectiveness and quarterly report status of PQR reports in QKPIs.
• Handling of received Customer Complaints ( starting from receiving of complaint, numbering, evaluation and investigation, impact assessment, set SMART CAPA, immediate action and CAPA follow up, closure and trending )
• Participate in different multidisciplinary teams and relevant activities as required.
• Perform other relevant tasks as required.

Responsibilities & Duties for QA - IPC Specialist:

• Review Batch record to ensure compliance of finished product.
• Perform inspection in production area , raw materials and finished product warehouse.
• Participate in non-conformities investigations to reach the root cause and set required CAPA.
• Participate in investigate of customer complaints and/or products recall.
• Perform supplier audits for primary and secondary packaging local supplier.
• Perform any additional tasks as requested.

Responsibilities & Duties for Internal Audit Specialist:

• 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:

• Bachelor degree in Pharmaceutical Sciences or Biotechnology.
• Experience:
• Specialist : 0-3 years of experience of relevant experience.
• Sr Specialist : 3-6 years of relevant experience.
• Basic cGMP guidelines.

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