Manager - Production

Job Description

To adhere with cGMP and GDP procedures applicable at site. To adhere with various administrative policies applicable at site. To initiate deviation, change control, CAPA in the Production Department within specified timelines. To initiate, review and investigate deviations / incidents / market complaints related to Production Department within specified timelines. To identify actionable CAPA based on deviation / Market complaint investigation and ensure timely implementation and closer of CAPA. To review CAPA effectiveness within stipulated timelines and ensure effectiveness closer. Periodic trending of deviation / incidents / market complaints related to Production Department and based on trend, facilitate identification of improvement actions (if any). Timely initiation and approval of extensions for investigation of deviation / incidents / market complaints, change control, CAPA before due dates. To prepare Quality Risk Assessment and ensure review and approval of same. Start to end monitoring of change controls for initiation, risk mitigation, approval, implementation, post implementation risk assessment (if applicable) and closer of change controls. To communicate and provide necessary training to doer, to ensure effective implementation of actions identified in change control(s) / CAPA / any other QMS documents. Maintain QMS documents, ensuring it is accurate, up to date and accessible. Ensure timely revision of document related to Production Department. Identify and address non-conformances and implement corrective and preventive action. Implement and maintain the QMS effectively in all the areas. Implementation and Documentation of ISO 9001:2015, ISO 14001:2015 and ISO 45000:2018. To co-ordinate with cross functional departments for timely approval / implementation / closer / of QMS activities. To draft response to audit (internal and external) observations related to Production Department. To ensure avoidance of breach of data integrity at all levels. To prepare and review BMR, BPR and SOPs of the Department.