The role involves coordinating day-to-day In-Process laboratory activities to meet turnaround times for critical real-time analysis across solvent recovery and drug-product operations
Job Summary
The role involves coordinating day-to-day In-Process laboratory activities to meet turnaround times for critical real-time analysis across solvent recovery and drug-product operations.
Candidates must ensure all testing activities comply with cGMP, DI requirements, site QMS, and safety rules while managing electronic data and documentation.
The position serves as the main auditee for regulatory inspections and supports the development of innovative medicines for Hepatitis C, HIV, and immuno-oncology.
Matching Summary
The role involves coordinating day-to-day In-Process laboratory activities to meet turnaround times for critical real-time analysis across solvent recovery and drug-product operations.
Skills & Requirements
Must-have
Minimum BSc in Chemistry or Life Sciences
Solid analytical laboratory experience in cGMP
Strong knowledge of GMP and quality systems
Hands-on experience with LIMS and Empower
Experience with change control and deviation management
Nice-to-have
Experience leading investigations and implementing CAPAs
Ability to work cross-functionally
Demonstrated problem-solving skills
Team player with deputizing capability
Continuous improvement initiative experience
Key Requirements
Minimum BSc in Chemistry or related Life Sciences discipline
Solid analytical laboratory experience in a cGMP environment
Competence with LIMS, Empower, Tiamo/LabX, SAP, Word, and Excel