Minimum qualifications
- Master’s degree in analytical science.
- Bachelor’s and master’s degrees in the pharmacy.
- 1-3 years of relevant experience in analytical method development and validation.
Roles and Responsibilities
- Execute routine Analytical Research activities on drug products.
- Troubleshooting related to Testing methods, Stability studies, test results, and designing of additional experimentations as necessary.
- Execution of Analytical Method validation activities for drug products as per the regulatory requirements.
- To conduct the API characterization and compatibility study for the formulation.
- Execution & coordination for Analytical method transfer activities of drug products.
- Preparation and review of Specifications, Method of analysis procedures, and Analytical development reports.
- Preparation and review of analytical protocols and reports (Analytical method validation, Method feasibility, Analytical method transfer, etc.).
- Assisting and resolving technical queries raised during Technology transfer activities & regulatory submissions.
- Assisting in the establishment of In-house Infrastructure (Analytical equipments Qualifications and preparation of SOP’s)
- Coordination with cross-functional departments.
- Handling of general laboratory instruments and equipments like HPLC, UV, GC, Dissolution, etc.
- Maintenance of laboratory chemicals and consumables.
- Troubleshooting of instruments in case of problems.
- Literature search.
- Documentation and data control.
Skills / Abilities
- Hands-on experience with HPLC, GC, and other routine laboratory instruments.
- Excellent computer skills, including Word and Excel and the relevant instruments software handling.
- Excellent interpersonal skills.
- Must have the ability to work under pressure, meet deadlines, and work on multiple projects simultaneously
- Experience in a regulated market is strongly preferred.
- Must have the ability to work independently.