About this role
Role Overview
- Perform comprehensive and detailed GMP compliance audits of animal health sites, contractors, business partners, and suppliers
- Support new business opportunities through the performance of due diligence, pre-contract, and Pre-PAI audits
- Responsible for accepting audit assignments, performing audit pre-work, conducting audits, and write-up of audit reports within defined timeframes
- Maintain an understanding of company policies, procedures, and guidelines
- Maintain awareness of evolving industry and regulatory trends/regulations
- Obtain and maintaining auditor qualification through ongoing training and continuing education programs
- Coordinate with Site Quality leads on audit refusals and postponements
- Lead project initiatives to maintain the effectiveness and efficiency of the audit program
Requirements
- Bachelor Degree in Engineering, Biology, Chemistry or related field
- Minimum of 5-7 years experience of manufacturing, technology, and/or quality experience within an FDA, an/or EU, API, Drug Product, Medical Device or equivalent environment
- Must possess “Subject Matter Expertise” in areas such as Medical Device/Combination products, Biologics, Vaccines, API’s, Non-sterile Drug Products, or Sterile Drug Product manufacturing
- Biologics auditing experience is required
- Thorough understanding of Quality Management Systems and process to support the manufacturing of drug substances, drugs products, and medical devices
- Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines
- Ability to work independently with limited supervision in a virtual-management environment
- Must have the ability to travel globally approximately 25% of the time.
Benefits
- Flexible work arrangements
- Professional development opportunities