Beschreibung

In this role, you will play a crucial part in enhancing Quality Assurance efforts, ensuring compliance with regulations, and actively supporting audits. Your day-to-day responsibilities will involve investigating quality issues and promoting a culture of quality awareness.

Anforderungen

• •Master’s degree in a scientific discipline
• •Minimum 2 years of experience in Quality Assurance within the pharmaceutical or GMP-regulated environment
• •Strong knowledge of GMP guidelines and hands-on experience with quality processes and risk management
• •Excellent communication and collaboration skills with cross-functional stakeholders
• •Detail-oriented, solution-focused team player with a proactive mindset

Aufgaben

• •Increase visibility of Quality Assurance across the company
• •Maintain and improve the Quality Management System
• •Ensure compliance with pharmaceutical regulations and GMP guidelines
• •Promote quality awareness and guide on quality systems
• •Ensure inspection readiness for internal and external audits
• •Investigate and resolve quality issues, including deviations and CAPAs
• •Review and approve SOPs and laboratory investigations
• •Review and approve analytical method validations and equipment qualifications
• •Monitor regulatory requirements and implement relevant laws
• •Strengthen cross-functional collaboration and report quality issues to management