Job Description
Job Description
Key Responsibilities
Key Responsibilities
- Project Management
- Plan, schedule, and oversee microbiology-related project activities, ensuring scope, timelines, and quality objectives are met in a GMP environment.
- Develop and maintain project plans, risk registers, action logs, and status reports; escalate risks and implement mitigation strategies.
- Coordinate cross-functional inputs (QC Micro, QA, Manufacturing, Validation, Supply Chain) to ensure readiness and on-time execution.
- Laboratory Methods and Operations
- Support and oversee testing activities for drug products and related materials, including endotoxin (e.g., LAL-based methods), sterility testing (per pharmacopeial requirements), and bioburden assessments.
- Ensure adherence to validated methods, SOPs, and data integrity principles (ALCOA+) in routine and non-routine testing.
- Partner with lab supervisors to al...
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