Aragen Life Sciences Limited

Unit-I

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Title : Job Responsibilities

JOB Responsibilities

Employee name : Bharat Dupakuntla

Employee code : 20874
Qualification : B Tech Chemical Eng.
Department : Technical Services Department
Designation : Deputy General Manager
Date of Joining : 14-Feb-2022
Reporting Manager : Kumaran Moghily Reddy
Job Responsibility Number : A-JR-18-20874-01

RESPONSIBILITIES
1. To follow the Good Manufacturing Practices (GMP), Data Integrity (DI) and Good
Documentation Practices (GDP) to ensure compliance and safety precautions.
2. Responsible for Process Improvements:
a) Identify bottleneck equipment’s and reduce the time cycle by process engineering
calculations and techniques.
b) Explore new techniques and technologies (contacting external parties if required),
generate User Requirement Specifications (URS) and ensure its completion.
c) Conduct GAP analysis between SOP and actuals and address the same.
3. Responsible for Manufacturing Excellence.
a) Study yield trends and identify critical factors impacting yield variations and to
eliminate / reduce yield variations with identified methods like DMAIC and using
Minitab. Calculate and analyse batch cycle time, identify bottlenecks & eliminate the
same for enhancing study capacity.
b) Drive & Implement operational excellence projects in line with Organizational
priorities.
c) Monitor capacity utilisation and plan to improve the same.

4. Responsible for Scale-up & Validation Support:

a)Review a detailed proposal (including Cost Proposal where applicable) on whether
existing facility is sufficient to support new scale up activities depending on the
business requirement.
b)Conduct facility and equipment mapping, equipment comparison. Decide on the batch
size based on various factors such as material properties, equipment capacities, market

Template Number: C-99-105/T002, Version: 00 & Effective Date: 07/Jan/2023

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requirements etc.
c)Communicate the information to production, monitor the batches during production and
review the BPR's prepared by documentation team.
d)Identify the deviations from the laid down process and inform production team for
correction.
e)Trouble shooting the issues during scale up and document the same. Support process
validation by monitoring the batches and troubleshoot in case of deviations.
f)Information sharing to the operating personal and supervisor staff on the new process
development & investigation root cause and CAPA.
5. Responsible for Risk management:
a) To carry out need based risk assessment as per SOP

6. Responsible for Create Safety awareness:

a)Participate in process hazard analysis (PHA) & risk analysis for new products, new
facility & scale-up facility and incident investigation report.
b)Participate in HAZOP and supporting Engg. Team in completion of hazop
recommendations
7. Responsible for Incident Investigations (Trouble shooting):
a)Coordinate with relevant stake-holders (QC, Engineering, R&D, Production & QA), call
for meetings, discuss and collectively arrive at the root cause for the deviation.
b) Making sure that all production deviations are reported and evaluated and that critical
deviations are investigated and the conclusions are recorded.
8. Responsible for Implementation of New Technology & Basic Detailed
engineering):
a)Identification of latest technology available in the market suitable for the company’s
manufacturing model.
b)Coordinating with vendor for trials and sizing of the equipment.
c) Involving & Preparing Basic & detailed engineering of new projects
9. Responsible for cGMP Compliance & Documentation activities:
a) Technical support to carry out adequately and timely investigation for Deviations,
Market Complaints, Quality information to find out the Root cause; CAPA
implementation to prevent reoccurrence.
b) Reviewing and distributing the instructions for the production of intermediates or APIs
according to written procedures.
c) Making sure that validation protocols and reports are reviewed and approved.
d) Reviewing all production batch records and ensuring that these are completed and
signed

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e) Evaluating proposed changes in product, process or equipment.

f) Making sure that new and, when appropriate, modified facilities and equipment are
qualified.
10. Responsible for Audits & Training :
a) Audit - To participate as team member of internal audit.

Delegation of Duties:
In absence of the job holder, assigned designee, under guidance of department lead/head will
ensure the above stated responsibilities are carried out.

Ref No. of JD Employee Code Name Sign & Date

A-JR-04-21034-00 21034 Kumaran Moghily Reddy

CHANGE HISTORY
Job
S.
Responsibility Changes Made Reason
No.
Number
New job Responsibility has been
ALPL/JR/ prepared accordance to the Job
01 Not applicable
04/20874/00
role.
Job Responsibility updated to in
A-JR-18-20874- Template updated as per
02
01 line with the current SOP. current SOP C-99-105.

Template Number: C-99-105/T002, Version: 00 & Effective Date: 07/Jan/2023

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Title : Job Responsibilities

Employee: Head of Dept.: Head – HR : Head – QA :

Date : Date : Date : Date :

Template Number: C-99-105/T002, Version: 00 & Effective Date: 07/Jan/2023