Officer/Executive Packing

Sr. No.

Responsibilities

1.0

Monitoring of Line clearance activity.

1.1

Line clearance of area and Equipment's as per checklists of SOP at various stages of manufacturing and packing activity.

2.0

Monitoring of in process activity.

2.1

In Process control as per mentioned in SOP and batch records at various stages of manufacturing and packing activity.

3.0

Monitoring of cGMP practices at shop floor.

4.0

Verification of documents.

4.1

Review of temperature, relative humidity and differential pressure records, Operational and Cleaning records of equipment and instruments and related documents.

5.0

Handling of QMS related activities.

5.1

Handling of Deviation and preparation of related investigation at the shop floor.

5.2

Initiation of Change Control Form, Deviation and CAPA.

5.3

Handling of Predictive maintenance and Breakdown memo as and when required.

5.4

To prepare the URS for the critical equipment and instruments as and when require.

5.5

To review the market complains and prepare the investigation reports.

6.0

Review of process data.

6.1

Review of batch manufacturing and batch packing records during batch processing and after completion of batch processing.

6.2

Review of Logbooks randomly.

6.3

Review of batch manufacturing record & batch packaging record

6.4

Review and approval of stage wise yield.

6.5

To compiles the BMR / BPR before submission to QA for final approval.

6.6

To review the preventive maintenance documents of equipment.

7.0

Documents Handling.

7.1

Preparation and Review of SOPs.

7.2

Preparation and Review of Equipment Equivalency Report for Tech Transfer Batches.

7.3

Preparation of protocol as and when requires. 

7.4

Filing of online rejection form as and when required.

7.5

Filling of additional request as and when required.

7.6

Initiation of predictive breakdown and breakdown as and when required.

8.0

SAP related Work (Not limited to).

8.1

Process order release, Generation of requisition slip, Bulk & Finish Product test request, SFG & FG quantity confirmation, Excess Material reversal, Generation of bonding slip.

9.0

Handling of Registration samples.

9.1

Check the stock availability and plan for the packing of registration samples.

10.0

Handling of Training Records.

10.1

Trainings to new employee and existing employees for modules and SOPs.

10.2

Training to workers, officers and operators in tablet manufacturing and Packing Area and maintaining record of the same.

10.3

Preparation of Training Need Identification and Summary of SOP training.

11.0

Monitoring of Maintenance activity.

11.1

Monitoring of post preventive maintenance and post breakdown activity.

12.0

Monitoring of Productivity norms.

12.1

Control and maintain rejection, wastage, relabeling & repacking and ensure the yield as per standard yield norms.

13.0

Handling of Standard weights.

13.1

Storage and verification of Calibration of Standard Weights.

14.0

Self-inspection / Audit

14.1

To handle self-inspection of tablet department.

15.0

Miscellaneous activity related to routine production

15.1

Monitoring and handling of Compliance related activity at shop floor on daily basis.

15.2

Prepare of the CAPEX and take approval from management for procurement of any critical & costly equipment.

15.3

To educate and guide all down staff employee on daily basis to follow and adherence of the SOP's.

15.4

To take part in webinars related to quality aspects and give our takeaways.

15.5

To analyze and evaluate the existing facility with standard procedures and amend the validate procedure in the operating SOP's if required.

16.0

Production and Planning

16.1

Preparation and Review of monthly Planning (Start to End) as per PPMC.

16.2

Preparation and Review of weekly Planning as per monthly plan.

17.0

Additional responsibilities assigned by Head of the department.