Title:  Technical Support Unit Officer

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.