Senior Officer
Job Description
PurposeThe candidate shall have the role of Analyst in Analytical development lab to support pharmaceutical formulation development i.e., Solid/ Liquid oral products/Nasal Spray/ Injectables.Position / Job TitleSr. officerDepartmentAnalytical research and developmentReporting ToAssistant General ManagerLocationThane.Years of Experience4 to 6 years Dosage FormLiquid Oral, Solid oral, ophthalmic, Nasal Spray, Injectables and Semisolid dosage form Job Responsibilities / Deliverables- To perform method development and validation for Assay, organic impurity, Preservative content and Dissolution method by HPLC.
- To perform analytical method validation/ Pre-Validation of Assay, organic impurity, Preservative content and Dissolution method by HPLC.
- Reverse engineering of Reference listed drug product.
- Responsible for Handling instruments like HPLC, GC, KF, Osmometer etc.
- Responsible for calibration of analytical pH meter, Balance, KF, and HPLC
- Responsible for writing LNB and preparation AMDR and Validation Reports,
- Responsible for ensuring compliance with GLP, Safety and Environment requirements.
- Participate in training session.
- Participate effectively in investigations related to deviations/incidences and to suggest CAPA.
- Coordination with cross functional teams for document approvals.
Qualifications & Pre-Requisites
- M. Pharm/M. Sc
- Knowledge of handling HPLC and GC.
- Exposure to Dissolution method development/validation and testing
Additional notes
- Candidate is expected to work in all shifts.
- Candidate is expected to visit external sites as per projects requirements