Production Officer-API

Sarthee Consultancy; India; On-site; INR 350,000 - 520,000; Full time

Job summary

Sarthee Consultancy in India seeks a production compliance assistant to ensure GMP/GDP/GxP adherence, safety norms, and policy compliance across shift operations in a manufacturing facility.

You will support shift in-charge, review BMRs, coordinate QC sampling, calibration, maintenance requests, and document GMP records, while training in cGMP, QMS, and EHS as scheduled.

Qualifications

• GMP/GDP/GxP adherence
• Safety norms compliance
• Document/control experience beneficial

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.

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.