Download Darmasagaram Swathi +91 9986467346 swathi20988@hotmail

Darmasagaram Swathi
+91 9986467346
[email protected]
Career Objective:
In pursuit of career enhancing opportunities in the field of Technology Transfers, Formulation
Development , Regulatory Document Support and utilize my experience for delivering quality
services to contribute towards organizational excellence.
Professional Summary:
An acclimatized professional with nearly 3+ years of experience in leading Formulations
Manufacturing and Healthcare Services.
 Preparation & review of Tech transfer Documents.
 Handling of product complaints and providing CAPA for the same.
 Preparation and Review of MPR, BPCR and analysis reports.
 Compilation ANDA / Dossier and submission of annual updates for ANDA / Dossier.
 Logging and handling the investigations for deviations, OOS and providing CAPA for the
same.
 Change control management.
 Provide support to the various divisions for effective and efficient implementation of the
Quality Management System.
 Co-ordinate with Production, QC, warehouse and Maintenance.
 Impart and Coordinate the training on SOP’s and GMP & GDP practices.
Work Experience:
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Worked as Technical Services Associate for “Dr Reddy’s Laboratories, Unit – FTO 2” in
“Technical Transfer Group” from April 2012 – November2014.
Currently working as Technical Writer for Apotex Research Private Limited , Bangalore in
Formulation Development Department” effective from January –2015 till date.
Educational:
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P.G Diploma: Clinical Research and Clinical Data Management, Global Hospitals Clinical
Research School (2012-2013).
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B.Pharmacy: R.B.V.V.R Women’s College of Pharmacy, Osmania University. (20062010).
Strength:
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Leadership Quality - Interface with internal mid & senior level management
Quality Focus
Evaluation, Gap Analysis& Trouble Shooting
Accountability
Learning attitude and logical approach
Versatile in adapting to new challenges in work.
Darmasagaram Swathi
+91 9986467346
[email protected]
Functional Expertise Support:
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Review of master documents such as Production and packing records, Process Validation
Protocols & Reports.
Coordinate with Production, QA, QC, Stability and other related departments for smooth
technology transfer of new products.
Assisting manager in Internal and External Quality Systems Audits and the CAPA
implementation.
Change control management. (Handling of Track wise Software for both change controls
and investigations).
Ensuring reconciliation and effective tracking of approved protocols, validation execution
from validation start point to end point, data/document compilation, and preparation of
validation report with summary, errors identified.
Execution and monitoring of Feasibility / Scale up / Exhibit or Process qualification batches
for NDA/ANDA filing.
Execution of Experimental / Placebo batches for root cause analysis of scale up / exhibit
batches.
Execution of the process optimization and exhibit batches protocols.
Hold time Study Protocol and Report.
Assist the manager in compliance of Quality systems (change controls, deviations,
Incidences etc).
Lead periodic reviews and implement a lean and efficient transfer process.
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Lead scale-ups, tech transfers, validations and technical interventions
Participation in validation activities for ensuring compliance to approved protocol and on
line documentation.
Perform investigation and root cause analysis for OOT, OOS, Incidents
Preparation of all relevant documents required for site transfer of a product (Technology
transfer Packages).
Preparation of Batch Manufacturing Records and Batch Packaging Records.
Preparation of Reports & Protocols like Process Validation, Process Verification, Hold Time
Study, Stability Protocols.
Preparation of the process optimization Protocols and Reports with the data generated
during optimization and exhibit batches.
Process Performance Qualification / Verification Protocol and Report.
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Responsible to coordinate, participate in risk assessment wherever required.
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Review and approval of Submission batch report for regulatory filing.
Review of intended and executed Master Production Record’s and executed Batch
Production Records.
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Review of Master Formula Records, Batch Manufacturing Records, Batch Packing Records.
Process validation Protocols and records
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Sampling Protocol and Stability Protocol.
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To plan the batch sizes for Process optimization and exhibit batches to meet the
equipment capacities and regulatory requirements with minimum consumption.
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Updation of Master list of documents.
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Verification of validation /sampling protocol before and after approval.
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Preparation and Review of Standard Operating Procedures
Imparting Training on SOP’s, GMP and GDP Practices.
Handling of Training records and ensuring the employees are trained with appropriate to
their job responsibility
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Darmasagaram Swathi
+91 9986467346
[email protected]
Personal Dossier:
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Name
:
D Swathi.
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Date of Birth
:
20-09-1988.
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Language Proficiency
:
English, Hindi and Telugu.
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Marital Status
:
Engaged.
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Present Address
:
BTM Layout, Bangalore – 560 029.
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Alternate Contact
:
+91 7760 395 258.
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Preferred Location
:
Bangalore.
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Reference
:
Can be provided.
Declaration:
I hereby declare that all the information above furnished is true for the best of my knowledge.
(D. SWATHI)