Quality Manager
Lambda Therapeutic ResearchJob Highlights
Required Skills
Job Description
Role Summary: We are seeking an experienced and meticulous Quality Manager to oversee and maintain the quality management system within our clinical research operations. The ideal candidate will ensure compliance with all relevant regulatory guidelines and internal SOPs, driving continuous improvement in quality standards.
Key Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with GCP, GLP, and relevant regulatory requirements (e.g., ICH-GCP, Schedule Y).
- Conduct internal audits and support external audits by regulatory authorities and clients.
- Manage and oversee the CAPA (Corrective and Preventive Actions) system, ensuring timely resolution of deviations and implementation of preventive measures.
- Review and approve study-related documents, including protocols, amendments, reports, and SOPs.
- Provide training to staff on quality-related matters and regulatory compliance.
- Monitor and report on quality metrics and performance indicators to senior management.
- Ensure vendor qualification and ongoing quality oversight of third-party service providers.
- Stay updated with evolving regulatory guidelines and industry best practices.
About Lambda Therapeutic Research
Lambda Therapeutic Research is a leading Clinical Research Organization (CRO) headquartered in India, with a global presence. Established in 1991, Lambda has evolved into a full-service CRO providing a comprehensive suite of services to the pharmaceutical and biotechnology industries. They specialize in early-phase clinical trials, bioequivalence studies, clinical development, and regulatory affairs. Lambda is committed to delivering high-quality, cost-effective solutions to its clients worldwide, adhering to international regulatory standards.
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