About this role
• 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. • 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.