OFFICER

1.0

Equipment and area qualification activity:

1.1

To perform the equipment qualification (SAT/ IQ/ OQ / PQ) like labelling machine, Blister machine, Cartonator machine, Track and trace system, Visual Inspection and Leak Testing Machine, Stretch Banding Machine and Weighing Balance as per VMP and approved protocol.

1.2

To perform the area and facility qualification for ampoule and vial line as per approved procedure.

1.3

To perform the visual inspectors qualification activity as per the SOP.

2.0

Packing Activity:

2.1

To monitor the online inspection with leak test detection activity done as per the SOP.

2.2

To monitor the labelling and de-labelling activity done as per the SOP.

2.3

To monitor the packing activity done as per the SOP.

2.4

To perform the calibration and verification of weighing balance as per the frequency.

2.5

To maintain the Inward and outward record of quarantine area.

2.6

To monitored the Lux level of visual inspection booth as per SOP.

3.0

To ensure the RH, Temp. DP of the respective area within the acceptance criteria.

4.0

Area and Equipment Cleaning Activity:

4.1

To ensure the cleaning & sanitization of controlled area as per the SOP and activity to be recorded in relevant GMP documents.

4.2

To ensure the cleaning & sanitization of fully automatic packaging line machines.

5.0

To generate the maintenance memo if any breakdown occurred in machine and also coordinate with engineering department.

6.0

To ensure the material movement in production areas as per the respective SOP.

7.0

Training and Documentation:

7.1

To complete the training within timeline.

7.2

To follow GDP while doing documentation work.

7.3

To update and ensure the status label (In process, Equipment, current status etc.) for area and equipment’s.

7.4

To record the activity in respective GMP documents.

7.5

To filled the online documentation (BMR, BPR, Logbooks or other GMP documents) during routine activity.

7.6

To prepare the SOP, protocols and documents related to the production parenteral (Packing) facility.

8.0

To perform / involved in the area and equipment qualification and requalification activity as per the respective protocol and documents.

9.0

To handle and operate the computer, IPC based software system during batch processing and entering the batch activities in batch packing record (BPR) or respective formats.

10.0

To handle the QMS activity like deviation, change control, CAPA etc.

11.0

To handle manpower and work distribution as and when required.

12.0

To handle the packing area operations in case of power failure or AHU shutdown.

13.0

To ensure the daily verification or challenge test of packing equipment done before start of the activity.

14.0

To execute, installation and commissioning of equipment / system.

15.0

To operate SAP transaction as per SOP.

16.0

To ensure safety during execution of project and production related activities.

17.0

Any other work assign by area supervisor or HOD.