
Quality Assurance Manager
2 days ago
Job Overview
The Assistant General Manager is responsible for overseeing large teams and ensuring the successful completion of testing and method validation activities.
This role requires strong leadership skills, analytical knowledge, and the ability to make informed decisions.
Key Responsibilities:
- Lead teams of 30+ members in QC, including the AMV team, for regular testing/method validation activities.
- Provide backup support to the QC HOD with daily updates, commercial output, monthly sample status, training, monthly review meetings, and coordination with all stakeholders.
- Execute and approve different types of QMS (OOS, OOT, investigation, etc.) and identify scientific root causes with effective CAPA while maintaining lab compliance.
- Design and execute planning of analysis (routine work, method validation, and method transfer), data interpretation, and present to HOD.
- Be self-driven, make self-decisions, and be a good learner. Provide guidance to team members for improving work quality and monitor and report on key performance indicators (KPIs).
- Lead all types of QC-AMV work in the absence of QC-HOD and actively participate in departmental improvement programs to enhance output and quality.
- Collaborate and coordinate with cross-functional teams like QA, RA, R&D, and PMI to proceed with allocated tasks with ownership and accountability.
- Stay updated on industry developments and emerging trends to remain competitive for LC-MS and FT-NIR techniques.
- Ensure adherence to GLP and Health, Safety Environment system in the laboratory and face FDA Audit (US, MHRA, EU) individually.
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