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.

- Robust 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.

📌 Research Officer - ADL (Navi Mumbai)
🏢 RPG Life Sciences
📍 Navi Mumbai