Technical Support Pharmacist At Hikma Pharmaceuticals
Title: Technical Support Unit Officer / R&D Pharmacist
Description:
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