·Candidate should have very good educational and theoretical background with able to provide solution to complex analytical challenges.
·Having experience to understand the customer compliance and manage multiple project deliverables.
·Candidate should have knowledge of calibration, method development and troubleshooting using various instruments like KF auto titrator, dissolution (I, II & IV), spectroscopic instruments e.g. UV spectrometer, IR and Chromatographic instruments e.g. HPLC, GC
·Knowledge of various regulatory guidelines w.r.t. method development, product development and documentation.
·Knowledge of method development for oral dosage forms w.r.t. tests like assay, degradation products, dissolutions, blend uniformity, content uniformity, cleaning method, etc.
·Sound knowledge on the specification setting for oral dosage forms, in-process specifications as well as product specifications.
·Should be well versed with raw material and packaging material specifications.
·Operating of instruments like LC-MS, GC-MS, LC-CAD, IC/ICPOES/ICPMS shall will be added advantage.
·Good understanding of Documentation as per GxP requirements
o Online Lab notebook writing
o Method development report preparation – Assay, Degradation products, Dissolution, cleaning method, etc.
o Method of Analysis, Test report, SOP preparation
o Calibration documentation
o Review of documents.
·Should be able to search scientific literature on-line
·Should be a team player and able to coach and guide juniors technically
Key Responsibilities:
·Drive projects with understanding of customer compliance and managing project portfolio.
·Routine analysis of samples
·Method development / method validation
·Instrument calibrations / qualification activities
·Documentation
·Report preparation
·Lab responsibilities and champion in EDMS/SDMS.
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