• 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.