Department Details

Role Summary

Role & Responsibilities
Job Description
• Implementation of QMS and GMP regulations in accordance to the regulatory guidelines.• Preparation and review of standard operating procedures in accordance to the regulatory guidelines.• Ensure Data Integrity, adherent to policies and its implementation.• Ensuring Preparation and review of Site Master File, Quality Manual and Organogram.• Preparation and review APQR of the product under review and to initiate necessary changes based on the final recommendations.• Document management and control - control of documents (master) and user copies of all master documentation. Labelling and Storage of master documents, validation documents and batch documents. Destruction of documents wherever applicable. Control on IOM, confidential documents and External documents. Issuance and control of batch records. Issuance, retrieval and storage of log-books.• Responsib...