Job Description
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
Qualifications
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
