Major Purpose Of The Job:- • 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. • Over seeing Manufacturing, Compression, Coating & Capsule filling related tasks including planning, control and trouble shooting. • Setting up production targets and achieve the same within time in Tablet Coating & Capsule Filling. • To review Daily Production plan for the Tablet Coating & Capsule filling 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 the process 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 SOP,s 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 and ensure the area and Equipment Cleanliness of Coating & Capsule cubicle, Coating Machine & its related equipment’s, Capsule filling machine & its related equipment’s, SS vessels & Environmental Condition suitability and in process checks to be carried out properly before startup and during batch Coating & Capsule filling. • 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.
