Head of Production

As a Production Head with 15 to 19 years of experience in pharma API pharma at Sandhurst Road Mumbai, your responsibilities include: - Reviewing, approving, and distributing work instructions for manufacturing activities. - Carrying out production activities as per the production plan. - Deciding on new batch production and monitoring batch processes. - Qualification of production equipment and participation in validation activities. - Checking the quality system in the production department. - Preparing equipment master lists and equipment qualification plans. - Reviewing MFRs, BMRs, BPRs, SOPs, and formats. - Ensuring that all production deviations are reported, evaluated, and investigated. - Evaluating and investigating all market complaints and implementing necessary corrective and preventive actions jointly with QA. - Initiating change control requests and evaluating proposed changes in product, process, or equipment. - Reviewing proper segregation of material, labeling, identification, area cleaning, and disinfection. - Monitoring production yields and reconciliation at various stages of manufacturing. - Providing training to personnel working in the production area. - Handling manpower and allocating it properly. - Preparing for internal and external audits and complying with technical audit requirements. - Documentation of cGMP and revising them as required. - Identifying the need for and procuring new machines and equipment. - Resource identification for the up-gradation of existing equipment and manpower. - Shift scheduling and sanctioning of production personnel. - Ensuring compliance with safety audit requirements. - Coordinating with warehouse/quality control for material availability/release. - Coordinating with engineering for maintenance/machine breakdown/modification. - Ensuring batch uniformity and integrity of drug products through written procedures. - Monitoring outputs and validating the performance of the manufacturing process. - Periodical review of SOPs related to production functions and informing QA for revisions. - Raising deviation and change-related issues to inform the QA department. - Participating in investigation and preparation of CAPA. - Verifying the function and performance of equipment/utilities. - Checking and verifying labeling and packing activities. - Participating in re-processing and reworking activities. - Checking and verifying gowning, usage of PPEs in processing and controlled areas. - Ensuring compliance with cGMP norms and environmental management system rules. - Investigating and implementing CAPA for environment-related incidents/deviations.,