Job Description Summary
-Supports all GxP activities in the Quality department.
-Administers Quality Systems/ Processes including documentation, metrics and monitoring of actions.
-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:
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones, Functional Breadth, Collaborating across boundaries
- 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
Work Experience:
- Quality Assurance
- Quality Control
- Quality Management Systems
- Technological Expertise
- Environmental Monitoring
- Release Management
- Good Manufacturing Practices (cGMP)
- Quality Compliance
- Technological Expertise
- Audit & Inspection Management
- SOP (Standard Operation Procedure) Management
- Documentation Management
Skills:
- Collaboration
- Dealing With Ambiguity
- Deadline Adherence
- Health & Safety Regulations Knowledge
- Monitoring
- Punctuality
- Regulatory requirements knowledge
- Problem Solving Skills
- Leadership
- Communication skills
- Data Integrity
- Digital saviness
Languages:
Skills Desired
Collaboration, Communication Skills, Data Integrity, Deadline Adherence, Dealing With Ambiguity, Digital saviness, Health & Safety Regulations Knowledge, Leadership, monitoring, Problem Solving Skills, Punctuality, Regulatory Requirements knowledge