Officer, Manufacturing Process Operations

Description:

Production personnel are responsible for carrying out day-to-day production activities as per approved Batch Manufacturing Records (BMR), Standard Operating Procedures (SOPs), and cGMP guidelines. The role includes handling raw materials, operating and cleaning equipment, maintaining accurate documentation, ensuring in‑process checks, following safety and quality standards, and supporting validation, trial, and routine manufacturing batches to ensure consistent and compliant production.

Essential Functions:

• To procure raw materials from Warehouse.

• Carry out the manufacturing operations according to the approved BMR.

• Carry out the cleaning operations according to the approved BCR.

• Perform the operations in accordance to the established SOP’s and cGMP & GDP and capture the data in relevant documents as and when the operation is completed.

• To execute batches every day as per the production schedule and as informed by the Shift in charge production.

• To record the batch position in the BMR from time to time without any delay.

• To follow & implement the cGMP during execution of the batches.

• To arrange for quality testing of in-process & intermediate stage material.

• To execute Development / Trial / Validation batches as per the specific steps mentioned in the concerned protocol.

• To ensure good housekeeping in & around the concerned production area.

• To maintain and to ensure daily log and stock books.

• To operate the equipment safely by following safety guidelines and wearing the personnel protective equipment during the execution of production activities.

• To attend the online training/classroom training of cGMP, GDP & Internal training [SOPs, Critical Process Parameters, cGMP and Operational Safety] classes without fail.

• To take the SOP (Periodic, revision, new procedure) trainings on online basis as per Pre-Uploaded AIMS Software.

• To maintain and calibrate the measuring devices in the concerned production block.

• To raise job orders for Preventive / Break down maintenance & Ensure preventive maintenance being performed and instruments are calibrated as per the schedule.

• To hand over the shift details / activities perfectly to the relieving Officer / Designee.

• Daily verification of electronic weighing balance as per procedure mentioned in respective SOP.

• To maintain the identification for each and every equipment by updating the status from time to time.

• To report any near miss accidents to the concerned superior and report the Process / System deviations to QA through a deviation report.

• To record daily monitoring data like temperature, humidity, differential pressure (if applicable), scrubber pH etc. of the respective production block.

• Carry out the packing activity according to the approved BPR.

• To undertake any other job as assigned by the Superior / Designee (Production).

Education:

• Bachelors Degree (BA/BS) B.E. - Required
• M. Pharm M. Pharm - Preferred

Experience:

• 2 years or more in 2 -4 Years

Specialized Knowledge: Licenses: