Opportunity Description
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
Requirements:
• Strong knowledge of validation tools, especially ValGenesis
• Experience with regulatory compliance
• Hands-on experience with CAPA processes
• Familiarity with 21...
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
Requirements:
• Strong knowledge of validation tools, especially ValGenesis
• Experience with regulatory compliance
• Hands-on experience with CAPA processes
• Familiarity with 21...
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