Pharmaceutical Quality Management Specialist
LTM
Elevate your career with LTIMindtree as a Pharmaceutical Quality Management Specialist. Leverage your knowledge of laboratory systems and regulatory compliance to drive project success in a supportive environment. This role focuses on handling Veeva Deviations and conducting root cause analysis within compliance frameworks. Strong understanding of 21 CFR Part 11 and GAMP 5 will be crucial in ensuring adherence to quality standards. You'll engage in raising ITCRs and CAPAs while monitoring system validations and deviations. Key Responsibilities:
- Manage pharmaceutical QMS laboratory systems lifecycle
- Process ITCR and IT CAPA submissions
- Conduct root cause analysis on quality issues
- Draft and execute qualification protocols
- Review user access for compliance adherence
- Strong knowledge of validation tools, especially ValGenesis
- Experience with regulatory compliance
- Hands-on experience with CAPA processes
- Familiarity with 21 CFR and GxP standards
- Ability to conduct post-implementation reviews
Vacancy posted 4 hours ago
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