Officer

Purpose

This candidate will primarily be responsible to Handling of all Compression machine and Encapsulation machine operations in shifts.

Position/Job Title

Officer

Department

Manufacturing

Reporting To

Section Head- Manufacturing

Location

Ambernath

Years Of Experience

2 -5 years

Dosage Form

Solid Oral

Job Responsibilities/Deliverables

Ensure that BMRs are available on shop floor before starting the production.

To check status label of machines and area, Temperature, humidity, differential pressure and online log book entries to take line clearance for next product or next batch of same Product.

To check calibration of balances/instruments in IPQC and preventive maintenance of equipment's.

Ensures compliance of all compression processes with Standard Operating Procedures (SOPs), cGMP, and safety requirements.

Coordinates issuance of blend and ensures execution of schedules (including changeovers, line start ups, and operations) within standard timelines.

Checks and maintains daily performance records, ensuring all related BMRs are properly documented; oversees reconciliation and rejection recording as per SOPs; monitors in process control checks and records them in BMR.

To give technical information sheet to QA for the analysis of samples withdrawn by QA during the process.

Ensures operators handle equipment and instruments safely.

Executes compression and encapsulation validations for new products or batch scale ups.

Prepares daily production reports, submits completed BMRs for review, verifies calibration of balances/instruments, and ensures preventive maintenance of equipment; reports incidents, handles deviations, and manages change controls when required.

Ensures new machine qualifications are carried out as per standard procedures.

Performs tasks assigned by managers and contributes ideas for process and machine improvement.

Handle and manage the respective shift manpower.

Qualifications & Pre-Requisites

B.pharm / M.pharm,

Must be able to work in shifts as needed

Should have working knowledge and exposure of compression machine like (Korsh Xm12. XL600, XL400 ,Fette P3030,Cadmac C-300 and C300 i) of OSD.

Total experience of 3 - 5 years in Supervision of Compression Machine and Encapsulation machine.

Knowledge of safe acts and behaviours and compliance to safety

Exposure of regulatory audits -USFDA, MHRA, TGA, ANVISA etc

Use of SAP systems

Command on operations and manpower in compression and capule section.

Additional Notes

Role is expected to work in all shifts.