A leading pharmaceutical company is looking for an Analyst to join its Formulation Analytical Development Laboratory (ADL) team in Vikhroli, Maharashtra. This full-time position falls under the R&D Formulations department within the Integrated Product Development division. If you have experience with analytical chemistry and pharmaceutical testing instruments, this is a great opportunity to contribute to product development and regulatory compliance.
Job Purpose
The Formulation ADL Analyst will be responsible for developing new analytical methods and conducting analysis of routine and stability samples to ensure smooth operations and timely delivery of products. The role demands expertise in Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs) to meet regulatory standards.
Key Accountabilities
- Analytical Method Development
- Create new analytical methods for analyzing routine and stability samples to aid formulators with accurate data.
- Instrument Maintenance & Calibration
- Maintain and calibrate instruments like HPLC, GC, Dissolution testers, and DPI-related instruments to ensure precise, reproducible results.
- Data Documentation & Compliance
- Record and interpret analytical data promptly as per GLP/GMP requirements to stay compliant with regulatory norms.
- Method Transfer & Collaboration
- Assist with the transfer of analytical methods and techniques by coordinating with other teams and visiting units as needed.
- Ensure Safety & Compliance
- Maintain a safe work environment by adhering to GMP, GLP, and safety protocols, minimizing risks of accidents.
- Specification Review & Recommendations
- Review analytical requirements and collaborate with cross-functional teams (CFTs) to recommend corrections in product specifications.
Challenges and Key Interactions
- Managing complex analytical data under tight timelines.
- Working with inter-departmental teams to ensure method transfers and product deliveries are on schedule.
- Staying up-to-date with the latest guidelines such as ICH, EMEA, and WHO for pharmaceutical testing.
Education and Qualifications
- M.Sc. in Analytical Chemistry or M.Pharm.
- 2-4 years of experience in a pharmaceutical organization with hands-on experience in:
- HPLC (High-Performance Liquid Chromatography)
- GC (Gas Chromatography)
- Dissolution Tester
- DPI-related instruments
