QA Associate

Job Description Summary

Supports all GxP activities in the Quality department. Administers Quality Systems/ Processes including documentation, metrics and monitoring of actions and supports establishment of Quality operational processes.
-Performs routine GxP Compliance/ Operational activities according to Novartis Quality Standards. Supports Quality Projects and initiatives

 

Job Description

Major Accountabilities:

• Maintains applicable Standard Operating Procedures (SOPs), GxP compliant documentation and records within the Novartis Quality Management System.
• Ensures the integrity of all Quality Systems records and data, as applicable and collaboration of own team with other functions and departments -Ensures an adequate level of education, GxP knowledge .
• Updates and maintains relevant information in electronic systems (e.g.Change Control, Documentation, Training).
• Follow up and monitoring of e.g.CAPAs, actions, metrics, Quality plan).
• Supports Quality Audits and Health Authority inspections.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Minimum Requirement

• Familiarity with Quality Management Systems is the pharmaceutical industry,
• Familiarity/experience within a Good Manufacturing Practices (GMP) atmosphere
• 1-2 years' experience in GMP documentation review, approval, and/or release would be ideal.

 

Skills Desired

Continued Learning, Good Documentation Practice, Guideline, Managing Ambiguity, Qa (Quality Assurance), Quality Management, Regulation, Self-Awareness, Technical Knowledge