Production Officer-API

Sarthee Consultancy; Pune District; On-site; INR 300,000 - 420,000; Full time

Job summary

Sarthee Consultancy in Pune is seeking a production quality professional to support GMP-compliant manufacturing operations. The role focuses on following GMP, GDP, GxP, and safety norms, and assisting shift in-charge in overall production activities.

Responsibilities include checking BMRs, ensuring in-process samples are sent to QC, receiving RM/PM from warehouse, calibrating equipment, raising maintenance MIS, performing in-process sampling per SOP, and maintaining GMP records and logs.

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.