Role: Team Member- AR & D
Role Band: R0
Reporting To: Team Leader- AR & D
Analytical Method development
Understand project requirements and timelines as per SLA requirements, participate in discussion meeting with R&D, conduct literature search, identify the equipment availability in consultation with supervisor IN ORDER TO develop new methods for required projects (intermediates, in process, raw materials and finished products)
Analytical Method Validations
Prepare protocols as per method validation SOP, perform validations, compile the validation report and get approval from Head - A R&D and submit to DQA/QA for their approval IN ORDER TO develop useful method for routine analysis in Quality Control
Regular Analysis & Calibrations of Analytical Instruments
Analyze the products for checking if that the product meets the laid down specification's ( STP's); check the performance of Analytical Instruments Like HPLC,GC,KF,UV,IR IN ORDER TO ensure regular analysis and calibration of instruments as per SOPs.
Document the procedures and results obtained IN ORDER TO ensure that proper evidence is collected for a particular product
Method Transfer to QC
Understand the QC protocols, perform the batch analysis, accuracy studies, LOQ studies as per protocol; prepare method transfer report, submit the report the QC, compile the results of QC analysis with AR&D analysis IN ORDER TO achieve acceptance of method by QC post matching
DMF Filing requirements
Provide method development report, method validation report, specifications and method of analysis of all stages, stability data and cut off studies of gentoxic impurities (if required) to QA/RA IN ORDER TO support the DMF filing from AR&D perspective.
Internal: Team Leader - A R&D, Manager- A R&D, Quality Control, RA, Validation cell, SCM
Technical Requirements: Deep understanding of pharmaceutical industry & products
Educational & Experience M.Sc( Analytical/ Organic Chemistry) with 2-3 years of experience
Key Attributes: Knowledge of various products and latest technological developments in the relevant market, Inter personal skills, Analytical skills & Communication skills.