- • Acts as lead auditor during Rockville Internal audits.
• Generates and obtains approval for audit plan on an annual basis. Holds meetings as required to review audit plan, as well as holding meetings to review and explain audit findings with designated members of management.
• Issues internal audit reports using existing format. Reviews responses for adequacy and communicates discrepancies with responses to owners. Assists owners as required with responses to ensure corrective actions as committed are implemented.
• Assists in the preparation for and participation in regulatory agency inspections, corporate and customer audits.
• Performs audit observation follow-up for global quality assurance audits and regulatory inspections as requested.
• Manages the site Self Inspection program.
• Acts as a student of current regulatory expectations and provides consultation to customers on interpretation of regulation and guidance published by regulatory agencies, industry.
• Participates in applicable root cause analysis teams to review and agree to the CAPA plan, the CAPA performance measures and the assessment dates.
• Verify that applicable CAPA has been delivered as committed and that the CAPA remains “in-place” and “in-use”.
• Monitors and reviews performance measures to ensure CAPA effectiveness.
• Issues and Processes site requests (Lab Notebooks, Logbooks and Documents).
• Maintains internal and external files for archiving and record retention programs.
• Assists in creating and administering training on procedures and GMP topics.
• Provide metrics to Manager and identify potential trends and gaps.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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