ry: We are seeking an experienced GMP Auditor to join our Quality Assurance team. The successful candidate will be responsible for ensuring compliance with Good Manufacturing Practices (GMP) and conducting thorough audits of our processes and systems.
Key Responsibilities:
- Conduct internal and external GMP audits to ensure compliance with regulatory requirements and company standards.
- Review and approve technical documents related to GMP analytical methods for small molecule drug substances and products.
- Evaluate and monitor the effectiveness of the Quality Management System (QMS) and recommend improvements.
- Ensure the accuracy, integrity, and availability of all GMP-related documents.
- Participate in the preparation and review of Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and other quality documents.
- Provide training and guidance to staff on GMP compliance and quality assurance practices.
- Investigate and resolve quality issues, including deviations, out-of-specification results, and non-conformances.
- Collaborate with cross-functional teams to support technology transfer and validation activities.
- Stay updated on changes in GMP regulations and industry best practice.
