Senior Analytical Research and Development Lead
6 hours ago
As a Senior Analytical Research and Development Lead at Inventia Healthcare Limited, you will be responsible for developing cost-saving analytical methods by QbD approach. This includes test methods like Assay, RS, Dissolution, cleaning methods, and method validation as per ICH guidelines for regulated markets.
You will be responsible for qualification and characterization of API received for product development, API DMF review for compliance to regulatory markets. Your expertise in reverse engineering and establishment of Q1/Q2 for products is essential.
You will work closely with the Regulatory Affairs (RA) Department to ensure submission of data required for regulatory filing related to Analytical Development. Additionally, you will be responsible for setting specifications for finished products and excipients for new projects assigned to the group.
You will ensure adherence to laboratory procedures, practices, and maintain laboratory equipment/instrument as per the GLP, EHS, and other statutory guidelines.
Key Responsibilities:
- Develop cost-saving analytical methods by QbD approach
- Qualification and characterization of API received for product development
- Reverse engineering and establishment of Q1/Q2 for products
- Work closely with Regulatory Affairs (RA) Department
- Setting specifications for finished products and excipients
- Ensure adherence to laboratory procedures and practices
• Sound knowledge of analytical research and development
• Excellent analytical thinking and problem-solving skills
• Competent in sophisticated analytical techniques
• Well-versed in ICH guidelines
• Strong understanding and evaluation of Nitrosamine, Elemental impurity assessment, Residual solvent assessment
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