Position Overview
- Ensure full compliance with Good Storage and Distribution Practices (GSDP) and all applicable regulatory requirements.
- Develop, implement, and continuously enhance the QMS.
- Manage quality events, including deviations, CAPA, change controls, and risk assessments.
- Conduct internal audits and actively participate in external audits and regulatory inspections.
- Act as a key point of contact during regulatory inspections, ensuring continuous inspection readiness.
- Maintain and control all quality documentation, including SOPs, policies, and records.
- Oversee supplier qualification, audits, and ongoing performance monitoring.
- Ensure proper storage, handling, and distribution conditions to maintain product quality and integrity.
- Review and release pharmaceutical products in compliance with approved procedures and regulatory requirements.
- Provide quality oversight of logistics operations and ware...