PurposeThe candidate shall have the role of an analyst in Analytical development lab to support analytical related deficiency responses. Replacement / New Recruitment / Internal Transfer Internal Transfer from Satara QC or Ambernath QCPosition / Job TitleSr. OfficerDepartmentAnalytical Research and DevelopmentReporting ToAsst.General ManagerLocationThaneYears of Experience3-6 yrsDosage FormSolid Oral / Liquid Oral/Injectables/Nasal SpayJob Responsibilities / Deliverables
Provide scientific justifications or perform analytical experiments (like Assay, RS, dissolution etc) to support regulatory responses.
Collaborate with cross-functional teams (QA, RA, QC, Formulation, etc.) to address deficiencies.
Investigate and troubleshoot analytical method issues cited in regulatory feedback.
Support the development or refinement of analytical methods to meet ICH and pharmacopeial requirements.
Execute experiments related to Assay, Organic impurities, Dissolution etc by HPLC or UV.
Ensure data integrity and compliance with regulatory standards.
Online logbooks, data and LNB entries and follow GMP / GLP practices.
Read technical papers, research articles, new guidelines and participate in internal scientific discussions.
Perform calibration of instruments as per schedule.
Providing technical inputs for troubleshooting, resolving issues, etc.
Preparation of study related protocols and reports.
Participate effectively in investigations related to deviations/incidences and to suggest CAPA.
Qualifications & Pre-Requisites
M. Pharm/M. Sc
Knowledge of handling HPLC, KF titrator and dissolution tester.
Exposure to Solid / Liquid Oral dosage forms.
Candidate should be good in technical / scientific writing.
Additional Notes
Candidate is expected to work in all shifts.
Candidate is expected to visit external sites as per projects requirements.
