Production Officer-API

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

Job summary

Sarthee Consultancy is seeking a production associate to ensure GMP/GDP/GxP compliance and support the Shift In-Charge in daily production activities.

You will check BMRs, coordinate with QC for in-process samples, receive RM/PM from warehouse, calibrate equipment including pH meters and balances, and raise maintenance notices.

You will report deviations, participate in training on cGMP, GxP, EHS, and maintain GMP records as required.

Responsibilities

• Follow GMP, GDP, GxP, Safety norms and adhere to company policy.
• Assist the Shift In-charge in overall production activities.
• Check BMRs and related records as per GMP.
• Ensure in-process sample/intimation slips are sent to QC.
• Receive RM/PM from warehouse.
• Calibrate and verify performance of equipments/instruments used at production facility (e.g., pH meter, weighing balance).
• Raise maintenance intimation slips (MIS) for maintenance work and ensure execution as per MIS.
• Perform in-process sampling as per SOP.
• Attend training on cGMP, QMS, GxP, GDP, EHS as scheduled.

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.