PurposeThe Officer/Sr. Officer (Granulation & Blending) will be responsible for leading and executing manufacturing activities related to Granulation and Blending processes. The role requires hands-on expertise with Granulation & Blender machines (Glatt -Integrated Line, Glatt FBP PRO, Anish, Tapasya, Saan, Bectochem ) in a cGMP-compliant environment, along with robust documentation and process adherence.Position / Job TitleSr. Officer- Granulation & BlendingDepartmentManufacturingReporting ToAssistant Manager (Section Head)LocationAmbernathYears of Experience5+ YearsDosage FormSolid Oral Job Responsibilities / Deliverables
Execute granulation and blending processes according to standard operating procedures (SOPs) and batch manufacturing records (BMR).
Handling documents like E-log, BMR, Process validation protocol, process validation reports etc.
Assigning the manpower as per the plan for there respective shift.
Monitor the work of operators and ensure that the necessary assistance is provided to them for their timely, adequate and accurate completion of the assigned work.
Overall machine knowledge of Granulation and Blending operating system.
Operate and maintain granulation and blending equipment efficiently and safely.
Record and maintain accurate production logs, batch records, and other documentation in compliance with GMP guidelines.
Identify and troubleshoot issues during granulation and blending operations to minimize downtime and waste. Participating in the process of validation, equipment qualification and optimization process.
Must be acquainted with Exhibit and Scale up process handling.
Calibration of the balances and other Instruments.
Checking and recording of the in-process parameter during manufacturing activity.
Troubleshooting of equipment by coordination with the engineering department.
To ensure safety and hygiene during manufacturing processes.
Train and guide junior team members or operators on process best practices and safety protocols.
Follow the shift in charge instructions to achieve departmental goal.
Responsible to carry out production operations as per production plan and delivery on time.
To report any incident or violation of GMP act to immediate supervisor/ shift in charge.
To carry out the activity in an effective manner to achieve departmental objective.
Additional responsibility of Preventive & regular Maintenance of machine
Monitored and ensured the products shall be run as per the batch cycle time derived and its batch cleaning time.
To ensure the Planned Preventive maintenance activity of equipments as per schedule and on time.
Must have knowledge about the Audit trial, Event log and reports.
Qualifications & Pre-Requisites
B. Pharmacy
Total experience of 5+ years in OSD formulation.
Should have good experience in the Granulation And Blending area.
Handling of Glatt Integrated Line (IGL), Glatt FBE, Tapasya SAAN, Bectochem.
Ability to work independently and as part of a team.
Problem-solving and analytical skills
Additional Notes
Role is expected to work in all shifts.
Must have exposure of regulatory Audits.
Adequate verbal and written communication skills.
Must have exposure of E-log system.
Additional benefits if candidates have E-BMR exposure.
