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Rgcc India
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Development Quality Assurance / Formulation Development Injectables

Development Quality Assurance / Formulation Development Injectables

Rgcc India

3 - 6 years

3 - 6 Lacs

Hyderabad

Posted:2 months ago| Platform:

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Skills Required

Document Review

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities Preparation and review of Development Quality Assurance Standard operating procedures. Responsibility for arranging training to new joinee and assessing. the training reports and periodic training. Knowledge in regulatory requirements & GMP guidelines. Experience in QMS & Audit procedures. Review of standard operating procedures related to FD, AD & all CFTs. Review of formulation development documents like trade dress for new product, feasibility report, justification for specification, scientific study protocol and report and pharmaceutical development report. Review of Analytical development documents like Analytical method validations, stability reports, Standard test reports etc. Ensuring the quality compliance like daily routine activities related to FRD & AD like Calibrations, Issuance of formats, Entry & Exit procedures etc. Number allocation for specification, method of analysis, laboratory standard testing procedure, analytical method validation protocol and report, analytical method transfer protocol and report, tooling specification, trade dress for new product, feasibility report, justification for specification, scientific study protocol and report. Secondary responsibility in ensuring, tracking, preparing the execution. and completion details of schedules such as equipment qualification and re-qualification, calibration, internal audit and preventive maintenance. Maintaining and improving the QMS. Monitoring the daily routine activities in all the cross functional departments. Conducting the weekly/monthly internal audits to ensure the quality compliance. Performing other activities based on the need as assigned by Head.

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Development Quality Assurance / Formulation Development Injectables