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Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code and enter data. Be fully competent to perform all steps within the case-handling processing.

Assist in submission of product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and support in handling post-approval changes, maintenance, and updation of documents during the products life-cycle. Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by collation, and compiling documents in order to ensure approvals for launch in stipulated time

Having good experience of method development on HPLC and GC instruments and other analytical instruments. Having knowledge of wet analysis

Candidates with experience in handling of sophisticated instruments e.g. HPLC, GC, UV, IR, Dissolution apparatuses and other laboratory equipment are preferred.

Exposure of QMS activities Exposure of Ampho, Bupivacaine Autoclave Operation and Supervision Lyo Operation and Supervision Regulatory Audit exposure Online documentation of BMR and log books during execution of batches

In-Process, FG and Stability, Analytical Instrumentation - HPLC, UV and Dissolution

D.Pharm, B.Pharm, M.Pharm with Gujarat State Pharmacy Council Drug License.

Analytical Method development. Handling HPLC, GC, UV IR, KF, Dissolutions

In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. Your primary interaction is within your own team and your direct supervisor