Research Officer - ADL

Job Purpose

To perform analytical method development support activities, method validation, method verification, and method transfer for pharmaceutical formulations. The role requires hands-on expertise in chromatographic and analytical instruments, preparation of analytical documentation, data interpretation, and compliance with cGMP, GLP, GDP, and regulatory requirements.

Key Responsibilities

• Perform analytical testing for pharmaceutical formulations such as Tablets, Capsules, Gels, and Syrups.
• Execute Method Validation, Verification, and Method Transfer activities for Assay, Dissolution, Related Substances, and Residual Solvents.
• Prepare Method Validation & Method Transfer Protocols and Reports.
• Independently prepare analytical calculation sheets in Excel for Assay, Dissolution, Related Substances, and Residual Solvents.
• Operate and maintain analytical instruments including:

1. Waters HPLC with Empower 3
2. Dissolution Tester (Auto Sampler)
3. Gas Chromatography (GC)
4. UV Spectrophotometer
5. Karl Fischer Titrator
6. Potentiometer

• Ensure compliance with GLP, GDP, GCP, and Data Integrity requirements.
• Maintain accurate analytical documentation and laboratory records.

Required Skills

• Hands-on experience with Waters Empower 3 and HPLC systems.
• Strong knowledge of Method Validation, Verification, and Transfer.
• Sound understanding of pharmaceutical analytical techniques and chromatographic practices.
• Proficiency in Microsoft Excel and Word.
• Good analytical, documentation, and problem-solving skills.

Experience - 5 to 7 Years

Qualification

• M.Sc. (Analytical Chemistry / Organic Chemistry) / M.Pharm or equivalent qualification.
• Relevant experience in pharmaceutical analytical development.