Sr. No.

Responsibilities

Frequency

1

Production planning and co-ordination with different department to run the department smoothly

Continuous activity

2

To ensure the products are produced and stored according to appropriate documentation in order to obtained the required quality.

Continuous activity

3

To plan and monitor the routine functions of all the areas of the production department viz manufacturing and packing.

Continuous activity

4

To participate in the investigations and give technical input with respect to complaints, events, incidents and failures.

As and when required

5

Ensure compliance with the quality systems-

• Cleaning validation master plan

• Equipment qualification master plan

• Process validation master plan

• Computer system

As and when required

6

To ensure the effective implementation of quality system procedure-

• Change control

• Unplanned deviation handling

• Area and equipment cleaning SOPs

• Shop floor observations

• Safety, Hygiene and sanitization practice

Continuous activity

7

Authorization of BMR/BPR after checking BMR/BPR as per approved copy of bill of material.

Continuous activity

8

To prepare monthly report and maintaining WIP.

Monthly

9

To review the instructions relating to production operations.

• Master batch manufacturing record,

• Work orders

• SOPs including the in-process controls and to ensure their strict implementations.

As and when required

10

To continuously review and identify the training needs of the individuals working in the department and conduct the training program for department

Continuous activity

11

Oversight of shop floor operations and practices including scrap management, building maintenance, during routine walk through to ensure strict adherence with respective SOPs

Continuous activity

12

To ensure the validation of the product manufacturing process and cleaning process in co-ordination with other department like QA, QC, Engineering.

As and when required

13

Implementation of cGMP system and to ensure their compliance.

Continuous activity

14

To report any abnormalities to immediate superior.

As and when required

15

To keep self-updated on the changes taking in the industry and the practices followed in the area of manufacturing on ongoing basis.

Continuous activity

16

Ensure that a timely and effective communication and escalation process exist to raise quality issues to the appropriate level of management.

Continuous activity

17

Participate in management reviews of process performance, product quality and quality management system and advocating continual improvement.

Continuous activity

18

To Co-ordinate, Review and Approval of

• Change Control

• Planned Modification/ Unplanned deviation

• Shop floor & Investigation reports

• Risk Assessment Report

• CAPA

• Executed Batch records

• Any other

As and when required

19

Authorized for review and approval of Protocol/ Reports of

• Exhibit/Stability batches

• Characterization batches

• Trial /study batches

• Process Validation

• Cleaning Validation

• Qualification

As and when required

20

To ensure Environmental monitoring of manufacturing area as per schedule

Continuous activity

21

To co-ordinate with contract giver and fulfil requirement as per responsibilities section in technical/contract agreement and extend support as per requirement

As and when required

22

To participate in the internal audit activity

As and when required

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