Assistant General Manager

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.