Technical Support Unit Officer - Giza
منذ 13 ساعة
وصف الوظيفة
:Job Summary
We are seeking a qualified and experienced Pharmacist to join our Technical Department, supporting sterile and oncology manufacturing operations. The role focuses on batch size scale-up, production troubleshooting, supplier qualification, and ensuring compliance with regulatory requirements. The ideal candidate will have strong technical expertise in sterile pharmaceutical manufacturing and a solid understanding of oncology product handling and GMP regulations.
Key Responsibilities
1. Technical & Production Support
- Lead batch size scale-up activities from pilot to commercial production.
- Optimize manufacturing processes to improve efficiency, yield, and product quality.
- Provide technical support to sterile and oncology production lines.
- Investigate and resolve production issues, deviations, and non-conformities.
- Participate in root cause analysis and implement corrective and preventive actions (CAPA).
2. Sterile & Oncology Operations
- Ensure compliance with aseptic processing standards and oncology handling requirements.
- Support validation activities including process validation, media fills, and cleaning validation.
- Review and approve batch manufacturing records and technical documentation.
- Ensure safe handling and containment practices for cytotoxic products.
3. Supplier Qualification & Technical Evaluation
- Evaluate and qualify new raw material and component suppliers.
- Review technical documents, specifications, COAs, and DMFs.
- Participate in supplier audits when required.
- Ensure materials meet regulatory and quality standards.
4. Regulatory & Compliance
- Ensure compliance with cGMP, FDA, EMA, and other applicable regulatory requirements.
- Support regulatory submissions and variation filings related to technical changes.
- Prepare and review technical documentation for audits and inspections.
- Stay updated on regulatory changes affecting sterile and oncology products.
5. Continuous Improvement
- Identify opportunities for process improvements and cost optimization.
- Support technology transfer activities.
- Collaborate cross-functionally with QA, QC, R&D, and Production teams.
Qualifications:
- Bachelor's degree in Pharmacy with grade Very good or Excellent
- Minimum Experience: 0-2 years of experience in same field
- Fluency in English, both written and verbal.
Location:
Giza, EG
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Job Summary · We are seeking a qualified and experienced Pharmacist to join our Technical Department, supporting sterile and oncology manufacturing operations. The role focuses on batch size scale-up, production troubleshooting, supplier qualification, and ensuring compliance wit ...
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