Purpose

This candidate will primarily be responsible to Handling of Bottle packing (Pharmapack/CVC/Parle), Blister packing (IMA-PG) and Sachet packing operations in shifts.

Position / Job Title

Officer/Sr. officer – Packing

Department

OSD Packing

Reporting To

Manager/Assistant manager - Packing

Location

Ambernath

Years Of Experience

2 -5 years

Dosage Form

Solid Oral

Job Responsibilities / Deliverables

Ensures compliance of all packing process in accordance with Standard Operating procedures and cGMP and Safety.

Coordinates for issuance of dispensed material. Ensures execution of schedules (including changeover, line start up and operations) as per standard time.

Checks and maintains daily performance and all related BPRs are properly recorded as per procedures. Ensures reconciliation and rejections are done and properly recorded as per Standard Operating procedures. To monitor in-process control checks and record in BPR.

Ensures start up and operations of serialization and aggregation system (includes batch creation, batch number download, operations & batch closure)

Ensures that operators handle equipment's and instruments safely

Ensures execution of packing validations for new packs and products.

To give daily production report and submit completed BPR to Department Head. To check calibration of balances/instruments and preventive maintenance of equipment's. Reporting of the incidence, handling of the deviation and change control whenever required.

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

Performs tasks assigned by managers. Provide ideas for process/machine improvements.

Qualifications & Pre-Requisites

B.pharma,M.pharma,M.sc

Must be able to work in shifts as needed

Skills Required

Should have working knowledge and exposure of all packing equipment's of OSD.

Total experience of 2 - 5 years in Supervision of Packing 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 & manpower in packing lines.

Operation of serialization equipment's

Additional Notes

Role is expected to work in all shifts.

Senior Officer