To ensure that cGMP practices shall be followed from the premises to their section. • To follow the all respective SOPs & BMR procedure in the department during operation. • To check and ensure environmental condition of Dispensing, Granulation, Compression, Coating, Capsulation, liquid and Packing area are maintained. • To check and ensure line clearance and labelling is done properly. • To check and ensure balances should be calibrated and verified as per SOP before operation. • To check and ensure all batches are dispensed and quantity to be verified as per BMR. • Over seeing Dispensing, manufacturing, compression, Liquid & Packing related tasks including planning, control and trouble shooting. • To review Daily Production plan for the Tablet and Liquid manufacturing activities. • To check and ensure dispensed batches for the day in advance. • To keep the area all time ready in line with c-GMP requirement. • To follow manufacturing of product as per the respective batch manufacturing record and do the in-process checks at specified time interval. • To follow up with maintenance for solving engineering related issues and keep follow up with the maintenance for on time rectification of break down. Principal Tasks:- • To maintain quality and productivity. • To ensure that Zero accident & Zero tolerance in the area. • To follow all respective SOPs BMR Procedure & Discipline in the department & Operation. Responsibilities:- • To follow proper Gowning / De-gowning procedure as per SOP. • To do the work allocation properly to workmen based on their competency to meet the daily Production Plan. Check and ensure that they are properly gowned and protected for the assigned work. • To keep the daily basis tracking for productivity of Manpower and Machines. • To check and ensure that all equipment’s used in the dept. are validated and their instruments are calibrated including the balances, ensure their cleanliness for use in good condition. • To check & ensure the cleaning & Operation of Granulation area, granulation equipment’s (Vibro Sifter & Sieve, Rapid Mixer Granulator, Loader, Fluid bed dryer & its Bag, Paste kettle, Stirrer, Co-Mill & Screen, Tipper, Multi mill & ScreenIR dryer, IPC bin, Electronic balance and Conta blender, Compression machine, Auto coater and Capsule filling Machine) and all the granulation utensils and Liquid manufacturing equipment’s as per SOPs. • To check and ensure the area and Equipment Cleanliness & Environmental Condition suitability and in process checks to be carried out properly before startup and during batch manufacturing. • To do the online entry and documentation in batch manufacturing record and other production records. • To prepare the investigation report, fill online deviations if any, and other quality document like change Controls, CAPA wherever necessary for the strengthening of quality systems. • To monitor the yield of every products stage wise on daily basis. • Participate in resolving the issues in the CFT being a team member, and a functional representative of the CFT. • To ensure processes needed for integrated management system for establishing, implementing and maintaining properly for your own department. • To participate in periodic IMS system audits and maintains the records. • To participate in training for internal auditors for IMS System to participate in various Awareness trainings on Environment, Health and Safety. • To interact with the cross functional team (QA/QC/RM/ENGG) for all technical and non-technical issue and resolve the same timely without affecting the product quality and delivery. • Co-ordinate with Maintenance regarding breakdown and preventive of equipment’s or facility. • Give necessary instructions to the operators for Production activities effectively. • Inform to superiors of any breakdowns, Deviations, HR issues, productivity issues. • Prepare and submit daily reports as required. • Check and ensure that all SAP related entries completed on-line • To do the API Calculation & Reconciliation in the Batch records.
