Team Lead
vor 6 Monaten
Team Leader - GxP Audit
We are seeking a qualified Lead Auditor to play a pivotal role in our GxP (Good Clinical, Laboratory, Manufacturing, Pharmacovigilance, and Distribution Practices) Audit Team. As the Lead Auditor, you will be responsible for the planning and execution of audits to evaluate GxP compliance, including GCLP, GCP, GDP, GMP, and GVP, in line with CSV (Computer System Validation) requirements.
**Responsabilities**:
- GxP Audit Planning: Collaborate with GxP Audit Program Owners and Quality Subject Matter Experts to define the GxP Annual Audit Plan.
- Audit Execution: Lead and oversee the execution of audits as per the annual audit program, ensuring adherence to standard operating procedures (SOPs) and department manuals.
- Audit Resource Management: Ensure that audits are properly staffed, conducted, and reported in compliance with established procedures.
- Audit Deliverables: Review draft audit plans and reports, and oversee the timely closure of audits, including the review and approval of Corrective and Preventive Action (CAPA) plans.
- Risk Management: Identify and escalate compliance issues and risks to senior management when necessary.
- Inspection Management Strategy: Contribute to the development and execution of the Inspection Management Strategy by collaborating with Global Process Owners (GPOs) and other Quality department leaders.
- Regulatory Authority Inspections: Support the preparation for and hosting of regulatory authority inspections, as needed.
- Knowledge Sharing: Provide key insights and strategic information derived from internal and external audits and related processes on a regular basis.
- Regulatory Knowledge: Stay informed about company policies, SOPs, drug development, manufacturing, distribution, FDA and EU regulations, and relevant international standards such as ICH guidance.
- Lead Auditor: Act as the Lead Auditor when required.
- Team Leadership: Lead and mentor the QA Auditor Team
**Your profile**:
- A university degree in Life Sciences or a related field.
- A minimum of 15 years of experience in the pharmaceutical industry, including responsibilities related to GxP compliance.
- Proficiency in conducting GxP audits and inspections.
- In-depth knowledge of GMP, GDP, GLP, and familiarity with EU, US, and RoW regulations.
- Exceptional verbal and written communication skills.
- Desired: Prior experience as an Inspector or in managing auditor teams.
Sounds like a great job?
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