EXECUTIVE

About the role

Acquainted with current Good Manufacturing Practice, pharmacopeia, different regulatory requirements and drug and cosmetic acts. Basic knowledge of microbiology, pharmaceutics, pharmaceutical chemistry, Biotechnology, Data Integrity, ALCOA and other related pharmaceutical subjects. Always ensure data integrity and compliance to quality and regulatory requirements.

What you'll do

• Work experience (in months)
• Ensure quality of drug product at difference stages
• Coordinate with compliance team and QAQMS for documents i.e. change controls, CAPA, Deviations, QRA, Technical document, Study Protocols and reports
• Handling of Internal audits and external audits, and to coordinate for department audits
• Ensure control on microbial contamination in manufacturing area by effective cleanliness of equipmentarea and following aseptic practices

What you need

• GMP
• Microbiology
• SOP writing
• Internal audit
• Documentation
• Chemistry