الجودة ريال متخصص في الموقع (محطات التكنولوجيا الحيوية)

Will adhere with the cGMP principles and perform Quality reviews as per Approved SOPs
Key responsibilities & Accountability:
1. Collaborate with Manufacturing, Validation and Engineering functions to drive Quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure Product Quality.
2. Perform a quality review on batch documentation received from manufacturing / packaging sites.
3. Perform a quality review of log books.
4. Involve/Lead in the investigations of site deviations/Market complaints/OOS and ensuring effective root cause analysis and assigning of appropriate CAPAs.
5. Prepare and review of Annual Product Quality Review reports.
6. Participation in Internal and Regulatory audits.
7. Compliance to current Good Manufacturing Practices (cGMP) or Good Distribution Practices (GDP).
8. Collaborates with functional departments to resolve issues and maintain compliance.
9. Actively participate in continuous improvement initiatives.
10. Have solid experience in microbiology and drug substance biotechnology manufacturing process (Growth Hormones and Mabs)
11. Have good knowledge of risk assessment principles and product assessment
Qualifications:
- Education
Bachelor/Master degree in Science/Pharmacy/Biotechnology
- Experience:
5-10 years in pharmaceutical industry preferably in Quality assurance or Production process having Biological Drug substances manufacturing.
Real Time Experience in the companies having GMP approval from USFDA/MHRA/TGA/ANVISA/EU authorities.
Flexible to work in all Shifts and not sensitive to B-Lactams
- Training:
Key Competencies:
Strong written and verbal communication skills for English language. Basic IT skills and knowledge in Microsoft office (word, excel, etc.)
Honesty & Integrity Self-confident.
Document (SOPs) and investigation Reports writing in English.
Technical Competencies:
Knowledgeable with Pharmaceutical cGMP Guidelines