+ Handling of investigation against Unplanned Deviation reported at workplace. + Handling of Cross Functional investigation against OOS/OOT reported at workplace. + Handling of Market product quality complain and its investigation. + Handling of CAPA reported against Deviation/OOS/OOT/Market complain. + Handling of Change control for system/process/equipment/Documents etc. + Handling of planned deviation and Temporary change control. + Handling of compliance report against regulatory observation/ CQA observation/ Internal audit compliance. + Planning & Execution of production and project activity from process side. + Monitoring and control of the manufacturing environment and plant hygiene. + Coordination with R&D, PDD, purchase department, Project, Dept. and QA documents for Block-D process and project related activity. + Planning and Execution of production activity. + Monitoring of compliance to requirement of current Good Manufacturing Practice, EHS, local and international regulatory norms. + To monitor departmental activities and ensure that all the department function are in compliance and as per expectations of customer/business and various stake. + To coordinate for external/regulatory GMP audits at plant and to ensure timely compliance of audit observations. + Adherence and implementation of companys policy of GMP and assurance of quality. + Prepare, review and approve of related SOP's and other GMP documents. + Daily, monthly, quarterly report analysis and short term or long term goal achievement. + Review and approval of QMS documents for new machines as well as facility/ system/process related activity. + Ensure and follow safety and GMP standards and compliance during shop floor operation. + Optimum utilization of man, material and machinery of pharmaceutical products. Adequate resource arability with focus of safety and quality first. + To ensure that products are produced and stored according to the appropriate safety, cGMP requirement and to ensure protection of the product from contamination and maintain quality as required. + To ensure approval or rejection as per approved procedure and by authorized personnel. + Supervision of proper production planning, plan execution of schedule as per work plan to meet the KPIs. + Inventory control of miscellaneous items in coordination with supply chain team. + To work closely with the Environmental Health and Safety department to ensure all members of the department are aware of safety policies to provide a safe workplace for employees. + To ensure compliance with all EHS policies, laws and regulations. + Participation in management reviews of process performance, product quality and of the quality management system and coordinating continual improvement. + Managing and coordinating process/GMP/GDP/DI related training activity as a people development program. + Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate level of management. + Execution of additional job assigned by higher / reporting authority. + To review and approve of BMR and PV protocol. + To intimate engineering for machine breakdown and follow up to machine/equipment back into the operation. + To review and approve SAP related activities. + To ensure lean management, operation excellence, GEMBA, yield improvement and waste reduction etc. with action plan and its implementation. + To ensuring that there are appropriate manufacturing and technical processes and procedures in place for the production. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. The production records are evaluated and signed by a designated person. + To prepare and Review the qualification related documents as URS, DE, FAT, SAT, IQ, OQ, PQ etc. + Any other responsibility assigned by management. We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.