Analyst IV
Summary
Conducts chemistry lab testing and documentation for drug products, stability samples, and complaints under GxP/GMP standards at Novartis, ensuring compliance and rapid reporting of technical issues.
Job Description Summary
-This role utilizes chemistry laboratory skills to test and measure product or materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical Methods and current Compendia.
Job Description
Major Accountabilities:
- Sample storage and management
- Analytical testing/documentation of drug product / finished product / complaints / stability / packaging material samples to GxP standards Stability
- Testing/Sample storage and management .
- Analytical documentation of stability samples to GxP standards
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable)
- Support method validation/verification execution
Key Performance Indicators:
- Orders are processed correctly and quickly.
- No waiting times due to wrong or delayed order.
- Deadline adherence rate: orders completed on time, all missed deadlines reported in good time, the shortest possible lead time
- Ensure constant readiness for inspection, no critical complaints from superiors and inspectors
- Consistently follow the GMP and GSU guidelines, as well as the SOPs, no critical irregularities
- Finding and implementing optimization options to reduce costs
- Completed training plan
Skills Desired
Chemistry Laboratories, Collaboration, Communication, Data Integrity, Deadline Management, Decision Making, Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Statistical Process Control (SPC)