Senior Auditor Position
We are seeking a Senior Auditor to join our Quality team. The ideal candidate will have a strong background in GxP quality systems and supplier management.
Main Responsibilities:
• Conduct remote audits of suppliers to ensure compliance with established criteria.
• Prepare audit reports and deliver results to suppliers within internal timelines.
• Evaluate corrective action plans to ensure they address observed issues effectively.
About the Role:
The successful candidate will be responsible for interpreting company policies, procedures, and regulatory requirements to make informed decisions. They will also be responsible for managing supplier quality agreements, including writing, editing, and reviewing agreements for approvals.
Requirements:
• Four-year degree in a relevant business or science field
• Minimum 3 years' experience in a GxP environment in the pharmaceutical industry
• Thorough understanding of FDA, PIC/S, and European regulations
• Industry and auditing knowledge, with relevant evidence
Preferred Requirements:
• 3-5 year-experience in a QA role in a pharmaceutical company, including global and/or regional audit responsibility
• Knowledge of Quality Systems and Supplier Management
• Experience in sterile and non-sterile product manufacturing, biological processes, laboratory operations, distribution