1. CURRICULUM VITAE
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PRABHASINI SAHU
Email:- prabha49797@gmail.com
C/o-Mr. P. Venkata Rao
Door No.: 9-5-61/2
Peethalavani Palem
(Near Kalabharthi)
Vishakhapatnam, Andhra Pradesh-530 003
Mobile No.- 09849174650,09617696328
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OBJECTIVE
Seeking position in the area of Quality Management Systems Compliance/Validation with a
challenging and responsible position with opportunity for advancement of potential where my
knowledge and experience will enhance productivity and effectiveness of organization.
PROFESSIONAL SUMMARY
B. Pharm with 6.7 years of experience and expertise in Quality management Systems-Change
Control,Deviation,CAPA,Self-inspection, Root cause Analysis, Risk Management, Batch Failure
investigation, Product Complainant,Recall,Batch document Review ,Batch release, Compliance to
Regulatory Inspection ,Validation-Packing line Equipment Qualification and packaging Validation,
in process Quality System and Compliance to Sterile formulation.
PROFESSIONAL EXPERIENCE
Organization Designation Department Duration
Hospira A Pfizer Company Executive Quality Assurance July 2013 to Till date
Cipla Ltd, Indore SEZ Management Staff Quality Assurance Feb 2010 to July 2013
Indoco Remedies, Verna Management
Trainee
Quality Assurance
Oct 2009 to Jan 2010
JOB PROFILE
Hospira A Pfizer Company.
Quality system and Compliance training
 Handling MQA qualification program and its assessment.
 Involved in walk through in production area for ensuring compliance on daily basis.
 Review of executed batch documents.
 Review of cleaning and usage log book on daily basis.
 Developing competency based training material for employees in in process Quality
assurance, production and Project & engineering.
 Initiation of change control by making red line documents pertaining its routing with
CCB team, impacted through the cross functional team signature ,implementing the

2. changes, and ensuring its effectiveness and closing of CCF by proving all objective
evidences.
 Evaluating impact based on change control as a member of change control board from
cross functional team. Initiating the incident with the initial impact assessment followed by
investigation, concluded the root case, establishment of corrective action, preventive
action and effectiveness check through Trackwise Software.
 Review of open change controls for any impact on batch release.
 Coordinated the CAPA investigator training as well as Trackwise Training by preparing the
training materials.
 Involved in preparation and execution of Compliance of FDA inspection.
 Involved in creating, uploading, and revision of new and existing procedure in ISOtrain
software followed with the process to keep in correct modules and subsequently assigning
those to relevant employees.
 Involved in internal audit and daily walk through and preparing response based on
observation.
 Involved in training of GDP and GMP training as a Qualified Trainer.
 Document Management including preparation of training presentation protocol preparation
and implementation, updating GxP registers.
 Distribution and retrieval of SOPs.
 Support for GMP Training activities using ISOtrain system.
 Routinely monitoring of ISOtrain software and iKAT Software for tracking of training.
 Involved in creation of new hires account in ISOtrain followed by assigning basic modules
as well as functional module upon request.
 Coordinated with the documentation cell and CCF team for uploading the procedure in
ISOtrain software on time.
 Coordination for trainer qualification ensuing training on timely manner and documenting
its master list for tracking.
 Routinely monitoring of daily issuance and retrieval of documents from QA training
document Storage area.
 Routinely monitoring of issuance ,retrieval of training attendance sheet followed by
its entries in software and review and finally storing of documents in appropriate
storage area for easy availability.
 Creation and uploading SAP related modules on ISOtrain followed by assigning to
relevant employees upon request.
 ISOtrain audit-trouble shooting in ISOtrain related problems.
In Cipla Ltd Indore SEZ
A. Equipment Validation and Qualification
 Involved in equipment qualification of packing line (Injectable).
 Involved in packing line validation using AQL.
 Preparation and review validation protocol, reports as required and coordinating with
production people in validation work and sampling ,execution of validation activity.
(IQ/OQ/PQ) and report compilation for the equipments , utility and facility validation and
finished products for regulatory level compliance.
B. In process checks Quality Assurance
 Handled the task like planning, implementing developing and maintain quality system
policies of IPQA related activities.
 To coordinate with different department like IPQA, production and R&D for submission of
regulatory documents timely. Managing and monitoring of IPQA activities across material
and process related to online data entries and quality compliance.
 Coordinated for compliance activity towards market complains.
 Review of calibration records

3.  Maintaining Finished Goods at Finished goods store.
C. Batch release activities
 Batch documents review and final compilation.
 Review of COA and Stability data.
 Coordination in Batch release activity.
 Generation and approval of packing list as a part of Batch release through Ensinc
software
D. Documentation:
 Initiation of change control by making red line documents pertaining its routing with
CCB team, impacted through the cross functional team signature ,implementing the
changes, and ensuring its effectiveness and closing of CCF by proving all objective
evidences.
 Issuance and retrieval of SOP and Issuance, retrieval and review of log books
 Review of unit operation of SOP regarding equipment.
 Handling of MMA (Master Management Application) software for simplification of Bill Of
Materials calculation in batch records.
 Generating item code of Raw materials through RMCA software.
 Generating pack codes through PMCA software.
 Generation and processing of –MBMR,MBPR,BMR,BPR,EMCM( Excess Material
Consumption Memo), EMRM (Excess Material Return Memo),OLRN(On line rejection
note),Daily Production Report through Production system software.
 Handling of SOPs & coordinating training.
 Conduct the training of SOPs to be implemented .Control, Retrieval & Issuance of SOP’s.
 Improvement, Continuous Review and Upgrading of existing SOPs.
In Indoco Remedies:
 In process checks in Tablets & Capsule.
 Batch documents review and final compilation.
AUDIT FACED
USFDA, MHRA, TGA, WHO, MCC and Customer audit
COMPETENCIES
 Keen observer, Good listener with self-belief and prospective nature.
 Optimistic approach towards Achieving Goals.
 Positive and friendly attitude, good pickup and keen learner.
 Hard working and flexibility.
 Accepting new challenges.
PERSONAL DETAILS
 Father’s Name : Mr.Narasingh Sahu
 Mother’s Name : Mrs. Tukeswari Sahu
 Date of Birth : 05th
May 1987
 Marital Status: Unmarried
 Languages Known : Hindi, English & Oriya
 Permanent Address: AT/PO-Tarbod, District- Nuapada, State – Odisha,
Pin Code: 766105
DECLARATION
I, Prabhasini Sahu, declare that the above information is true and correct to the best of my
knowledge and nothing has been concealed or distorted.
Vizag (Prabhasini Sahu)

4. Date: