Responsible for small volume parenteral manufacturing activities at Dholka premises. • To check hygienic condition of the workmen before entering to aseptic area, processing area and compounding area and maintain record. • To check and ensure entry exist procedure of workmen with proper gowning and sanitization. • To check and ensure that Temperature and differential pressure of the all area is within limit and record it properly. • To check on line in process parameters like temperature, RH, fill volume, quality of sealing at specific interval as mentioned in respective MMD-I and SOPs and record the same in BMR • To check and ensure that sterilization of the containers, equipment's, utensils etc. are as per respective SOPs. • To maintain equipment logs as per SOP • To ensure proper cleaning of the working areas. • To ensure proper status labeling as per Sop. • To ensure calibration certificates of all measuring instruments comply with norms. • To ensure plant wise cGMP compliance. • To meet agreed production targets with due compliance to regulatory norms. • To ensure proper utilization and productivity of manpower and machines. • To ensure all records/documents of department are maintained in compliance to regulatory. • To ensure optimization of resources and reduction of waste/rejects. • Ensure on – time in full delivery of Export & Domestic product as per monthly demand • To handle regulatory inspection and ensure Quality Compliance as per various Regulatory Requirements. • Ensure resource availability in terms of machines, materials and manpower for execution of the plan. • To ensure 100% compliance and review EHS activities on routine basis. • Review Loss of sale /Loss of production with all departments and ensure zero losses. • Review Quality Index KPIs like, Batch failure, CAPA implementation, Market complaints, Lab errors and ensure its compliance in time. • To ensure manufacturing of exhibit batches as per plan. • To ensure the cost-effective improvements & measure to control plant expenses. • Impart necessary training to all workmen, operator and supervisor staff. • Review SOPs and MMD- I and II for regulatory compliance and actual practices. • Interact and resolve issues with other departments like engineering, QC, QA, SCM, validation, CPLB and HR. • Co-ordinate with maintenance dept. regarding break down and PM of Equipment’s and facility. • To identify repeated problems of various Equipment’s and get it resolved permanently from Eng. Department. • Give necessary suggestion to supervisors for improving quality and quantity of the production. • Inform/discuss with HOD for any breakdown, deviation, HR issues, productivity, capacity, utilization, etc. • To ensure the work discipline and cleanliness in production areas.
