QA Assistant - fixed term

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 inspection.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Customer satisfaction -Punctuality rate -Jobs done on time, following the specified cycle time -Consistent compliance with GMP and Health, Safety and Environment guidelines and Standard Operating Procedures -No complaints with regulatory inspections

Minimum Requirements:
Work Experience:

• Functional Breadth.
• QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
• Collaborating across boundaries.
• cleanliness zones.

Skills:

• Continuous Learning.
• Dealing With Ambiguity.
• Gmp Procedures.
• Qa (Quality Assurance).
• Quality Control (Qc) Testing.
• Quality Standards.
• Self Awareness.
• Technological Expertise.
• Technological Intelligence.

Languages :

• English.