The role involves leading the formulation QA operations team to oversee critical manufacturing activities including weighing, mixing, cleaning, and disinfection
Job Summary
The role involves leading the formulation QA operations team to oversee critical manufacturing activities including weighing, mixing, cleaning, and disinfection.
Responsibilities include auditing production SOPs, optimizing quality management documents, and conducting comprehensive reviews of batch records and data.
The manager is responsible for handling product releases, managing non-conforming materials, and participating in investigations for out-of-specification events.
Matching Summary
The role involves leading the formulation QA operations team to oversee critical manufacturing activities including weighing, mixing, cleaning, and disinfection.
Skills & Requirements
Must-have
Formulation QA operations management
SOP audit and optimization
Batch record review and product release
Deviation and CAPA investigation
OOS event investigation participation
Nice-to-have
Technical transfer experience
Regulatory filing support
Supplier qualification assistance
Key Requirements
Bachelor's degree or higher in Biomedical Engineering or related field
8+ years total work experience (5+ for Master's graduates)
Minimum 5 years in pharmaceutical quality management
English proficiency at CET-4 level with full fluency