PurposeThe candidate shall have the role of Analyst in Analytical Method development to support pharmaceutical formulation development i.e., Solid/ Liquid oral products/Nasal Spray/ Injectables.Position / Job TitleOfficer/Sr. officerDepartmentAnalytical method developmentReporting ToSr. ManagerLocationThane.Years of Experience2 to 5 years Dosage FormLiquid Oral, Nasal Spray, Injectables and Semisolid dosage form.Job Responsibilities / Deliverables
To perform method development and validation for Extractable and Leachables, Nitrosamine and another specific impurity by LCMS (GCMS and ICPMS added advantage)
To prepare analytical method development report, Standard test procedure, Study protocol,
Responsible for calibration of analytical pH meter, Balance, and HPLC
Responsible for ensuring compliance to GLP, Safety and Environment requirements.
Participate in training session.
Participate effectively in investigations related to deviations/incidences and to suggest CAPA.
Execution of compatibility study samples analysis and preliminary assessment and conclusion of compatibility study
Reverse engineering of RLD.
Qualifications & Pre-Requisites
M. Pharm/M. Sc
Knowledge of handling HPLC, Analytical Balance, KF, Osmometer and pH meter.
Additional Notes
Candidate is expected to work in all shifts.
Candidate is expected to visit external sites as per projects requirements
