Job Information
Sun Pharmaceuticals, Inc Deputy General Manager - Manufacturing & Packing in India
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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