Regulatory Affairs Professional
15 hours ago
Key Responsibilities:
- Drive Global Risk-Based Audit Strategy Development and Implementation.
- Lead External GxP Audits for CMOs, Suppliers, and Service Providers, Ensuring Timely Completion and Effective Follow-Up.
- Deliver Internal Audits/Self-Inspections as Lead or Co-Auditor, Fostering a Culture of Continuous Improvement.
- Provide Regulatory Guidance and Recommendations to Ensure Ongoing Compliance.
- Ensure Timely Escalation and Resolution of Critical Findings, Including CAPAs.
- Prepare Audit Status Reports, Highlighting Trends and Performance Metrics.
- Support Authority Inspections and Partner Audits, Demonstrating Collaboration and Transparency.
- Maintain Expertise in Relevant Regulations, Including FDA, EU, and ICH, as Well as Internal Quality Standards.
- Author SOPs Related to GxP Audits, Enhancing Operational Efficiency.
- Offer GxP Compliance Consulting for Training, Projects, and Task Forces, Driving Business Growth.
Requirements:
- Life Sciences University Degree.
- At Least 10 Years Pharmaceutical Industry Experience with GMP/GDP Responsibilities.
- Strong Background in GMP/GDP Audits and Inspections.
- Preferably Experienced GMP Inspector or Auditor in Biotechnology and Sterile Manufacturing.
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