Senior General Manager

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 Good 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 all concerned man power in coordination with HR. • To qualify vendor of Raw & Packaging Materials. • To highlight and resolve quality related issues at manufacturing locations. • To ensure implementation of written procedures and guidelines. • To ensure functioning and related activities of the RQA department at F&D. • Responsible for Approval of Certificate of Conformance. • Responsible for batch disposition decision and Batch release documents. • Responsible for approval and authorization of Quality Documents viz. Quality Agreements, Declaration, submission documents. • To ensure completion of any additional task assigned by the senior management, if any.