Job Description
• As assigned, schedules, conducts and reports routine QA audits in accordance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
• Provides suitable recommendations for audit observations; ensures auditees provide appropriate CAPAs and follows them up through closure
• Participates in complex, directed and/or global QA audits
• Supports process improvement activities / SOP updates
• Supports client audits and regulatory inspections
• Participates in special projects
• Represents Audit QA on project teams and other internal forums
• Able to support client audits and regulatory inspections
Candidate Profile
• University/college degree BA/BS (life sciences preferred) or equivalent experience
• Knowledge, understanding and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs
• Knowledge of the drug development process from the perspective of a contract research organization
• University/college degree BA/BS (life sciences preferred) or equivalent experience
• Knowledge, understanding and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs
• Knowledge of the drug development process from the perspective of a contract research organization
Additional Information
Experience : 5+ year
Qualification : University/college degree BA/BS
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : QA&C
End Date : 31st January, 2019
Experience : 5+ year
Qualification : University/college degree BA/BS
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : QA&C
End Date : 31st January, 2019
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