Production Officer-API

Sarthee Consultancy; Gurugram District; On-site; INR 250,000 - 400,000; Full time

Job summary

Sarthee Consultancy in Haryana seeks a production professional to ensure GMP/GxP compliance and adhere to safety norms. You will assist the Shift In-charge/Block in Charge in day-to-day production activities and ensure BMRs and related records are maintained as per GMP.

You will also handle in-process sampling, coordinate with QC for samples, receive raw materials from warehouse, and oversee calibration and maintenance tasks. Training on cGMP, QMS and EHS will be provided as per schedule.

Responsibilities

• GMP/GxP compliance
• Assist Shift In-charge in production
• Maintain BMRs and GMP records
• Coordinate in-process sampling with QC
• Receive RM/PM from warehouse
• Calibrate and verify equipment
• Raise maintenance intimation slips (MIS)
• Perform in-process sampling as SOP
• Attend training on cGMP, QMS, GxP, GDP, EHS

Job description

Role & responsibilities :

• Responsible to follow the GMP, GDP, GxP, Safety Norms and adhere to company policy.
• Responsible to assist the Shift In-charge/Block in charge in overall production activities. . .
• Responsible to check BMRs & all related records as per GMP.
• Responsible to ensure that in-process sample/intimation slip are sent to QC department.
• Responsible to receive the RM / PM from warehouse.
• Responsible for calibration and performance verification of equipments/instruments being used at production facility, viz. pH meter calibration & performance verification of weighing balance.
• Responsible to raise the maintenance intimation slip (MIS) for all types of maintenance work & to ensure execution of maintenance work as per the MIS.
• Responsible to perform in-process sampling activity as per mentioned in standard operating procedure.
• Responsible to attain the training on cGMP, QMS, GxP, GDP, EHS, periodic training etc. as per schedule wherever applicable.
• Responsible to fill the BMR, BCR, FGPR, Logbook, In-process/Intermediate FG labels and all other GMP records required to execute the production activities & to maintain production facilities as per GMP requirement.
• Responsible to report deviation, safety permits & near miss/accident/incident reports as wherever necessary & coordinate during investigation.
• In absence of duties, respective designee is responsible for the activities to attend the regular activities as per the pre-planned schedule.