We are looking for a Research Associate Analytical R&D; with experience in Formulation Analytical Research & Development and analytical method development for Oral Solid Dosage (OSD) formulations.
Key Responsibilities
Perform analytical method development for Oral Solid Dosage forms such as Soft Gelatin Capsules, Modified Release Dosage Forms, Oral Suspension, Powder for Oral Suspension, etc.
Develop analytical methods in accordance with current regulatory requirements and expectations.
Perform analysis of development and stability samples for parameters including Assay, Related Substances (RS), Dissolution, Residual Solvents and Content.
Operate analytical instruments such as HPLC/UPLC, GC/Headspace, UV and FTIR.
Conduct analytical method validation as per applicable guidelines.
Prepare and review Specifications, Standard Test Procedures (STPs), protocols, analytical reports and related documentation.
Ensure compliance with Good Laboratory Practices (GLP) and established laboratory procedures.
Maintain accurate analytical records and ensure timely completion of assigned activities.
Apply strong analytical and problem-solving skills during method development and troubleshooting.
Required Skills
Solid knowledge of Pharmaceutical Analysis and Analytical R&D.;
Hands-on experience in HPLC/UPLC, GC/Headspace, UV and FTIR.
Experience in analytical method development and validation.
Knowledge of analytical testing of formulation and stability samples.
Positive understanding of GLP and regulatory requirements.
Positive documentation, analytical and problem-solving skills.