1. Arra Nampally
Asst.Manager
Sanofi India
Ph.: +91 9959862377
arranampally@yahoo.co.in
OBJECTIVE
To develop career in a reputed Pharma Company in the area of Pharmaceutical Formulations with
consistent updating of knowledge, skills, stretching my performance to the best and motivating team
members to achieve organizational objectives
SYNOPSIS
Dynamic, Result oriented professional with over 11.5 years of comprehensive experience in the Quality
Control department of Pharmaceutical formulations & QC Projects. Actively involved in
manufacturing of Injectable like sterile Dry Powders, Liquid Injections, Vccines, Tablets and
Capsules.
EDUCATIONAL QUALIFICATIONS
Completed Master of Science from Periyar University in 2002 to 2004.
Completed B.Sc., from Osmania University in 1999 to 2002
AUDIT EXPOSURE & FACTORY ACCEPTANCE TEST
Successfully faced many International and regulatory audits like USFDA, MHRA, MCC, WHO, EDQM ,
and GQA Sanofi.
Factory Acceptance Test: Attended FAT/Training on Fedegari Autoclaves in Italy on May-2016
Factory Acceptance Test: Attended FAT/Training on Sterility Test Isolator from Getting France on
May-2016
WORK HISTORY
CURRENT EMPLOYMENT:
1. SHANTHA Biomechnics (A SANOFI Company)
SANOFI is a WHO approved French based Biotech & Biopharmaceutical company, exploring its
business in India and Europe.
Duration : 13.Apr.2015 to till date
Position : Team Leader (Asst. Manager)
Department : Insulin Project -QC (Microbiology)
Reporting to : Sr. Gen.Manager / Project Head.
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2. Arra Nampally
Asst.Manager
Sanofi India
Ph.: +91 9959862377
arranampally@yahoo.co.in
Roles and Responsibilities:
Responsible for New Insulin Cartridge Enterprises (Insulin) Project Quality Control Microbiology.
Currently working with SANOFI India (which is manufacturing sterile Injectables) as Asst. Manager
by leading a group and responsible for the day to day smooth activities of the department,
balancing resources and work load, to achieve the department goals/ activities.
Overall Management of Microbiology Laboratory including supervision of
maintenance of all Equipment’s and Instruments used in Microbiology lab.
Preparation of URS for customized Equipments & Preparation of Laboratory layouts.
FAT/SAT & IQ/OQ/PQ Execution.
Qualification of all Equipment’s and Instruments in Microbiology lab.
Supervision of Microbiological water system qualification.
Handling of Project change controls.
Preparation of SOP’s, STP’s, Specifications, Validation Protocols and COA’s.
Review of Microbiology reports.
Review of validation documents.
Training of the team members.
Planning and Maintenance of BOM &Non BOM consumables.
Supervision of receipt and storage of routine samples for testing.
Handling of Projects Change controls, Risk Assessments,SLIA and Trainings.
Review and approval QC related SOP’s.
Preparation of Training Matrix for Quality control.
Attending the Webinars & Teleconference for Technology transfer of Insulin SFI.
Responsible to Initiate and Organizing +QDCI meeting on daily basis and tracking the issues.
Preparation/ Revision of URS as per the changes.
Failure Investigations and Risk Assessments and escalation of critical RISK to the corporate level.
Management of Global Documents to implement in the plant within as per the specified timeline.
Responsible to organize QRM on monthly basis.
Daily work assignment to the team members and routine monitoring of the progress and
completion of the assigned staff activities.
Responsible for implementing gap analysis in the plant as per new inclusions and amendments.
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3. Arra Nampally
Asst.Manager
Sanofi India
Ph.: +91 9959862377
arranampally@yahoo.co.in
Review and Approval of Validation protocols.
Notify the senior management, if the potential quality or regulatory issues that may impact the
product quality or regulatory compliance.
Personnel Qualification of the Personnel entering into Aseptic Area &Conducting training sessions
for the aseptic operators.
Media Preparation and GPT testing.
Compressed nitrogen sampling and analysis.
Sterility test for sterilized vials , sterilized rubber stoppers and products,
Sterility test for finished products by EQUINEX (Millipore)
Power failure study,
Validation study of Dynamic Pass box.
Validation of Aseptic garments/gloves
Microbial limit tests for raw materials and finished products and Stability Samples (As per
Harmonized, IP method).
Preparation of ROA as per the Specifications.
Preparation of disinfectants (diluted) which is using in the aseptic area.
Preparation of trends on monthly and yearly basis, for Environmental Monitoring and Water
Monitoring.
Registration of the Samples in SAP and Creation of AR Numbers in SAP
COA entries and Release of the Product through SAP.
TRAININGS AND SEMINARS ATTENDED
Attended training on” Quality Management System”
Attended training on” Computer System validation”
First Aid and Fire Fighting
Supplier Quality Audits
Attended Training on Hi Veg media’s and harmonized media by Hi Media laboratories.
Attended a Seminar on Filters and its Validation by PALL co-operation.
Attended a Seminar and Training on EQUINOX by Millipore.
Attended a Seminar conducted by USP.
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4. Arra Nampally
Asst.Manager
Sanofi India
Ph.: +91 9959862377
arranampally@yahoo.co.in
STRENGTHS
Hard working, Initiative, Planning, Mature and Energetic
PREVIOUS EMPLOYMENT
Bharat Biotech International Ltd.,:
WORK EXPERIENCE: July.2013 to Apr.2015.
DESIGNATION: Asst. Manager
Celon Laboratories Ltd.,:
WORK EXPERIENCE: Oct.2012 to July.2013.
DESIGNATION: Senior Officer
Hospira health care India Pvt.Ltd.,:
WORK EXPERIENCE: June.2008 to sep.2012.
DESIGNATION: Senior Officer
AUROBINDO PHARMA LIMITED:
WORK EXPERIENCE: June. 2004 to May. 2008.
DESIGNATION: Microbiologist
PERSONAL DETAILS
Date of Birth 07.01.1979
Marital status Married
Nationality Indian
Languages: English, Hindi, Telugu and Tamil
Permanent Address: Flat No.509, SVS’s Pavan Residency.
Doton Road, Machabollarum, Alwal
Secunderabad. 500010
Place:
Date: Yours Truly,
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