Altasciences
Drug Therapies
SeniorQAAuditor,GLP
“Senior QA Auditor, GLP at Altasciences. Skills: GLP Auditing, Regulatory Compliance, Quality Assurance. Carry out systematic examination of study activities. Determine compliance with protocol, SOPs, GLP”
Industry & Context.
Provides risk-based compliance opinions and guidance; Evaluates inspection finding responses to ensure they are written to address the findings appropriately; Involves manager when assistance in process improvement/resolution is necessary
What They're Looking For.
Must Have
Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience, Two to three years related technical experience and/or training, Minimum of two years auditing in a GLP-regulated environment, Microsoft Office Suite, Good communication (both written and verbal in French & English)
Nice to Have
Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality– Certified Quality Auditor) or other certification is recommended
What You'll Do.
Carry out systematic examination of study activities
Determine compliance with protocol
Report findings to Study Director
Audit nonclinical and laboratory studies
Perform process audits
Maintain computerized files
Support project planning
Provide risk-based compliance opinions
Write and issue inspection reports
Evaluate inspection finding responses
Ensure SOPs are current and practiced
Identify opportunities for process improvements
Maintain documentation of QA records
Notify management of quality trends
Perform SOP QA review
Perform external test site qualifications
Interpret FDA guidance
Recommend modifications in procedures
Interpret and train on GLP
Carry out self-development efforts
Assist with regulatory training
How You'll Work.
Team & Collaboration
Build and maintain effective working relationships throughout the organization; Work with internal clients to ensure findings are communicated; Participate in and guide process improvement activities
Communication Scope
Good communication (both written and verbal in French & English)
Process & Methodology
Support project planning and implementation
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