Job Description

The Manufacturing Officer is responsible for executing day-to-day production activities in compliance with approved Batch Manufacturing Records (BMR), Batch Cleaning Records (BCR), SOPs, and cGMP/GDP requirements. The role ensures timely batch execution as per the production plan, accurate documentation, equipment operation and maintenance coordination, adherence to safety standards, and effective shift handover in an API manufacturing environment.

Key Responsibilities

Procure and issue

raw materials from the warehouse

as per approved documents. Execute

manufacturing operations

strictly in accordance with approved

BMRs

. Perform

cleaning operations

as per approved

BCRs

. Ensure all operations are carried out in line with

SOPs, cGMP, and GDP

, with timely and accurate documentation. Execute

daily production batches

as per the production schedule and shift in-charge instructions. Record

batch status and processing details

in BMRs without delay. Arrange and coordinate

in-process and intermediate quality testing

with the QC department. Execute

development, trial, and validation batches

as per approved protocols. Ensure

good housekeeping

in and around the production area at all times. Maintain

daily logbooks, equipment logs, and stock records

. Operate production equipment safely by following

safety guidelines

and using prescribed

PPEs

. Attend

online and classroom training programs

on cGMP, GDP, SOPs, CPPs, and operational safety. Complete

SOP trainings

(new, revised, and periodic) through the

AIMS system

. Ensure

calibration and maintenance

of measuring devices in the assigned production block. Raise

job orders

for preventive and breakdown maintenance and ensure activities are completed as per schedule. Perform

daily verification of electronic balances

as per SOP. Maintain

equipment identification and status labeling

. Record

daily environmental monitoring parameters

such as temperature, humidity, differential pressure, and scrubber pH (where applicable). Carry out

packing activities

as per approved Batch Packing Records (BPR). Ensure proper

shift handover

to the relieving officer/designee with complete details. Report

near-miss incidents

to concerned executives and raise

deviation reports

to QA for process/system deviations. Perform

any other duties

assigned by the Executive/Designee (Production)

Other Responsibilities

Ensure strict adherence to

data integrity (ALCOA) principles

during documentation and batch execution. Participate in

internal audits, regulatory inspections, and customer audits

by providing required production-related information. Support

continuous improvement initiatives

to enhance productivity, quality, and safety. Ensure compliance with

EHS guidelines

, waste segregation, and safe chemical handling practices. Assist in

risk assessments

and implementation of corrective and preventive actions (CAPA). Ensure proper

material identification, labeling, and traceability

throughout the manufacturing process. Monitor and report any

abnormalities, breakdowns, or deviations

during batch execution in a timely manner

Qualification & Experience

Qualification:

B.Sc. / M.Sc. in Chemistry or Diploma / B.Tech in Chemical Engineering or a related discipline.

Experience:

4 to 8 years

of relevant experience in

API Manufacturing / Production

in a pharmaceutical environment.

Key Skills & Competencies

Strong knowledge of

API manufacturing operations

Hands-on experience with

BMR, BCR, and BPR documentation

Good understanding of

cGMP, GDP, and safety requirements

Equipment operation and

basic troubleshooting skills

Knowledge of

calibration, preventive maintenance, and validation activities

Strong

documentation and compliance mindset

Ability to work in

shift operations

and handle multiple batches Good communication and

coordination with QC, QA, Warehouse, and Engineering

* Awareness of

data integrity and deviation management