Summary
About the Role
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.
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