Description:
- To ensure compliance of plant as per cGMP requirements laid down by various international and national regulatory bodies. To update quality systems & procedures in accordance with the current regulatory expectations and guidelines. To ensure successful audits by various international / national regulatory bodies and compliance. To ensure product Licenses permission are maintained/ renewed timely for all products manufactured at the facility. - To ensure the implementation and maintenance of Current Valuable Manufacturing Practice (cGMP) standards and international quality standards in main Pharma. - To ensure that the product meets the defined standards for strengths, identity, safety, purity and quality by various system-driven approaches. - Create and maintain Quality Systems that are in compliance with various quality standards and regulations that mainly include FDA Regulations. - Ensuring timely reporting of OOS, OOT, FAR and Deviations, adequate root cause investigations and compliance to scheduling and completion of resulting action items.



- To ensure timely review and approval of change controls, deviations, OOS, OOT, CAPA and QMS documents. - To hold the manufacturing and packaging processes, if the norms are not followed and work is compromised as per Good Manufacturing Practices and the Standard Operating Procedures requirements. - Monitoring of Quality KPI & Quality council meetings. - Planning and scheduling of compliance audit at sites for all time readiness of regulatory audits. - To review and update quality system and procedure of Warehouse, production, QA & QC to meet the international / national CGMP requirements. - To ensure smooth technology transfer of new product to plant level sign the Technical Agreement with customers. - Authorizations of SOPs, MMD I, BPR, Qualification & Validation protocol & reports, Quality Manual, VMP, SMF,QMS, PQR Validation documents and other Master documents. - To ensure cGMP related training program for

📌 Senior General Manager (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka