Sr. No.
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Responsibilities
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Frequency
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1
|
|
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2
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To ensure the products are produced and stored according to appropriate documentation in order to obtained the required quality.
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Continuous activity
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3
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To plan and monitor the routine functions of all the areas of the production department viz manufacturing and packing.
|
Continuous activity
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4
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To participate in the investigations and give technical input with respect to complaints, events, incidents and failures.
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As and when required
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5
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Ensure compliance with the quality systems-
- Cleaning validation master plan
- Equipment qualification master plan
- Process validation master plan
- Computer system
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As and when required
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6
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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 practice
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Continuous activity
|
7
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Authorization of BMR/BPR after checking BMR/BPR as per approved copy of bill of material.
|
|
8
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To prepare monthly report and maintaining WIP.
|
|
9
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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.
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As and when required
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10
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To continuously review and identify the training needs of the individuals working in the department and conduct the training program for department
|
Continuous activity
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11
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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
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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
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Implementation of cGMP system and to ensure their compliance.
|
Continuous activity
|
14
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To report any abnormalities to immediate superior.
|
As and when required
|
15
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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
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16
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Ensure that a timely and effective communication and escalation process exist to raise quality issues to the appropriate level of management.
|
Continuous activity
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17
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Participate in management reviews of process performance, product quality and quality management system and advocating continual improvement.
|
Continuous activity
|
18
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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
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As and when required
|
19
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Authorized for review and approval of Protocol/ Reports of
- Exhibit/Stability batches
- Characterization batches
- Trial /study batches
- Process Validation
- Cleaning Validation
- Qualification
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As and when required
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20
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To ensure Environmental monitoring of manufacturing area as per schedule
|
Continuous activity
|
21
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To co-ordinate with contract giver and fulfil requirement as per responsibilities section in technical/contract agreement and extend support as per requirement
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As and when required
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22
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To participate in the internal audit activity
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As and when required
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