The role involves leading the complete setup and validation of a new QC laboratory to ensure efficient workflow and GMP compliance
Job Summary
The role involves leading the complete setup and validation of a new QC laboratory to ensure efficient workflow and GMP compliance.
Candidates must establish robust quality control procedures and maintain accurate documentation practices to guarantee product safety and data integrity.
The position requires coordinating with cross-functional teams to support the commercialization of biological drug products while managing internal and external audits.
Matching Summary
The role involves leading the complete setup and validation of a new QC laboratory to ensure efficient workflow and GMP compliance.
Skills & Requirements
Must-have
GMP system development and maintenance
Lab establishment and equipment qualification
Regulatory compliance with FDA and EMA
Analytical testing method validation
Root cause analysis and CAPA implementation
Nice-to-have
Cross-functional collaboration skills
Project management experience
Continuous improvement initiatives
Stakeholder communication abilities
Key Requirements
Bachelor of Science in Pharmacy, Chemistry, or Biochemistry
Master's degree in analytical science of Biological Product
At least 4 years' experience in analytical testing and method validation of biologics
At least 2 years' experience in project management