О роли
Lead QC laboratory operations and analytical testing. Perform HPLC, microbiology, and physical analysis. Review and approve test data. Manage QC team. Ensure GMP compliance and data integrity. Issue product release/rejection recommendations. Maintain laboratory documentation and LIMS records.
Требования
Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related field
Minimum 5-7 years of QC experience in pharmaceutical injectables
Expertise in analytical testing (HPLC, microbiology, physical testing)
Strong knowledge of USP/BP/IP standards and GMP guidelines
Excellent attention to detail and data integrity practices
Proficiency in laboratory LIMS and documentation systems
Lead quality assurance activities in the QC laboratory. Perform analytical testing including HPLC, microbiology, and physical analysis. Review test data and issue release/rejection decisions. Manage QC team and conduct training. Ensure compliance with USP/BP standards and regulatory requirements. Maintain LIMS data integrity and laboratory documentation.