:
1. Conduct formal investigations of process deviations and complaints, ensuring adherence to relevant Standard Operating Procedures (SOPs).
2. Perform risk assessments to evaluate the potential impact of deviations and complaints on product quality, operational processes, and patient safety.
3. Collect, analyze, and apply information from internal and external sources to support accurate, thorough investigations.
4. Evaluate the impact of deviations on previously packaged products and assess the potential risk for future operations.
5. Lead and support cross-functional investigations involving Packaging, Clinical Labeling Services, Distribution, and other departments to ensure timely resolution and closure.
6. Collaborate with key team members to identify probable root causes and define effective corrective and preventive actions.
7. Conduct trend analysis of deviation and complaint data to identify patterns and implement continuous improvement measures.
8. Act as a liaison between Production and Quality departments to ensure alignment and effective communication throughout the investigation process.
9. Independently manage investigations, ensuring they are completed within required timelines and in accordance with regulatory expectations.
10. Observe packaging and distribution floor activities to gather first-hand information critical to understanding the process and the deviation context.
Qualifications:
11. Strong knowledge of GMP (Good Manufacturing Practice) standards and deviation management principles.
12. Excellent analytical, problem-solving, and technical writing skills.
13. Ability to work independently and in cross-functional teams.
14. Experience with risk assessment tools and root cause analysis methodologies (, Fishbone, 5 Whys).
15. Proficiency in using quality systems such as TrackWise is a plus.