Sr. Officer / Executive - MSTG

Full time

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Responsibilities

To coordinate with different departments i.e. Formulation development (FDD), Analytical development (ADD), Packaging development (PDD), Production, Engineering, Quality control, Quality Assurance, Supply chain, Business development, Project management and any other department for timely execution of New projects.
To plan, monitor and support for execution of the trial batch, exhibit batch, scale up/characterization batch and process qualification batches
To prepare and review new product documents like material requirement sheet, master formula card, bill of material, risk assessment reports, scale up protocol and reports, exhibit/ trial batch manufacturing record and exhibit protocols and reports etc
To provide the regulatory response and technical justification
To initiate the gate pass for sample transfer at various sites of Sun Pharmaceutical Industries Limited
To prepare and review approve new launch documents i.e. material requisition sheet, product history, trial/ characterization protocol and report, batch manufacturing record, process qualification protocol and reports etc
To share process knowledge to cross functional departments through presentation for smooth technology transfer
To review and evaluate product history and process parameters for technical remediation and improvement of product robustness
To prepare and review investigation report/Justification report, additional activity protocol, regulatory evaluation etc

Qualification & Experience