To support and execute analytical development activities for formulation products, including analytical method verification, optimization, validation and transfer, along with analytical troubleshooting, stability studies and protocol-based studies in compliance with ICH, GLP, GDP, FDA and EMA guidelines.
Key Responsibilities
1. Analytical Method Development & Validation
- Perform method verification, method optimization, method validation and method transfer as per ICH guidelines.
- Support analytical troubleshooting related to formulation products and analytical methods.
- Travel frequently to different locations/sites for method validation, method transfer and analytical troubleshooting activities.
2. Instrument Handling
- Hands-on experience with analytical instruments including:
- Prepare, review and maintain analytical protocols, reports and logbooks.
- Ensure compliance with Valuable Laboratory Practices (GLP) and Good Documentation Practices (GDP).
- Maintain analytical documentation in accordance with applicable procedures and regulatory requirements.
6. Quality Management
- Experience in handling LIR & QMS activities.
- Ensure analytical activities are performed in compliance with established quality systems.
7. Regulatory & Guidelines
- Strong knowledge of relevant ICH guidelines.
- Good understanding of FDA and EMA guidelines related to analytical activities.
- Ensure analytical activities and documentation comply with applicable regulatory expectations.
8. Software & Data Handling
- Computer literacy with hands-on experience in analytical data handling software such as: