Operate and manage production tasks including pipeline assembly, sterilization, and solution preparation, while overseeing outsourced staff and ensuring timely sample delivery
Job Summary
Operate and manage production tasks including pipeline assembly, sterilization, and solution preparation, while overseeing outsourced staff and ensuring timely sample delivery.
Maintain production department cleanliness, manage personnel changing rooms, draft and update SOPs, track issues, and oversee outsourced cleaning services and waste disposal.
Support equipment calibration and validation, participate in risk assessments and change controls, identify GMP compliance and operational risks, and implement CAPAs to enhance efficiency and quality.
Matching Summary
Operate and manage production tasks including pipeline assembly, sterilization, and solution preparation, while overseeing outsourced staff and ensuring timely sample delivery.
Skills & Requirements
Must-have
Production task completion
SOP document drafting
GMP compliance
Risk assessment participation
CAPA implementation
Waste inactivation and disposal
Nice-to-have
Team collaboration
Problem-solving skills
Continuous efficiency improvement
Key Requirements
Bachelor's degree or higher in Cell Biology, Molecular Biology, or related field
2+ years of experience in solution preparation, aseptic techniques, and GMP production
Extensive GMP experience, commercial production experience preferred
Practical experience with deviation investigation, CAPA, and change control
Good documentation skills, ability to draft SOPs and batch records