:

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 valuable 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.

📌 Senior Executive (Jammu)
🏢 DigiCAD
📍 Jammu