Deputy General Manager
1 month ago
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 systemAs and when required
6
To ensure the effective implementation of quality system procedure-
Change control Unplanned deviation handling Area and equipment cleaning SOP’s Shop floor observations Safety, Hygiene and sanitization practiceContinuous 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 SOP’s 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 SOP’s
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 otherAs 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 QualificationAs 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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