Analyst IV
Summary
Analyst IV performing sample management, analytical testing, and stability documentation of drug products in a GMP-regulated pharmaceutical manufacturing lab, ensuring GxP compliance and supporting method validation.
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
Job Requirement:
- Minimum 3 years of experience in a GMP-regulated pharmaceutical or biotechnology environment.
- Hands-on experience in sample management, storage, and analytical testing of drug products, finished products, stability samples, packaging materials, and technical complaint samples.
- Strong understanding of GMP/GxP requirements, including laboratory documentation practices, data integrity principles, and quality compliance standards.
- Experience in stability testing, analytical documentation, and laboratory investigations within a regulated environment.
- Excellent attention to detail, documentation, and problem-solving skills.