1. Satish reddy Mandala
# 9-52, Old Vysa bank,
Nambur (P.O), Pedakakani (M.O),
Guntur (D.T),
Andhra Pradesh,
INDIA.
To
THE HUMAN RESOURCE MANAGER
Sub: - Application for a suitable post in your esteemed organization
Respected Sir/ Madam,
I hold a Master’s degree in Pharmacy with Specialization in Pharmaceutics from S.R.M University,
Chennai, Tamilnadu.
I’m currently exploring job opportunity. I believe my qualifications and experience to be consistent
with those required at your end.
Throughout my education and job career, I’ve attempted to stay all rounded combining academic
excellence with leadership.
I’ve been exposed to all the facts of Industrial and Analytical aspects. Enclosed is my resume for
your review.
I would like the opportunity to meet and share more about my Qualifications and the ways in which
I can contribute to the team.
Awaiting an early and favorable response from your company.
Thanking You,
Yours Sincerely
(SATISH REDDY MANDALA)
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2. SATISH REDDY MANDALA
S/O: M.Veera Reddy,
H.No:9-52, Old Vysa Bank,
Nambur, Guntur District,
Andhra Pradesh.
Pin code: 522508
satish.mandala19@gmail.com
+918008257000
OBJECTIVE
• Effective utilization and development of my intellectual power and skills in Pharmaceutical
sciences to add value to the organization through individual efforts as well as team work.
• Seeking a responsible position in an organization, which gives me a chance to improve my
knowledge, enhance my skills and enable me to strive towards the overall development of the
organization and can also give me a growth of professional career.
PROFESSIONAL EXPERIENCE
• Presently Working for DR.REDDY’S Laboratories Ltd, Formulations Unit-3 (FTO-3),
Bachupally, Qutubullapur, RangaReddy (DT), Andhrapradesh, India as an Assistant manager
in Quality Assurance department from February-2014 to till date.
• Worked for Natco Pharma Ltd, Pharma Division, Kothur (Mand), Mahaboobnagar (Dist) as
an Officer in Quality Assurance department from October 2012 to February-2014.
• Worked for LEE PHARMA LTD, Formulations & Projects, Vizag as an Officer in Quality
Assurance department From May-2011 to October-2012.
AREAS OF INTEREST
• Quality Assurance.: Audit Complains, Market Complaints, QMS, Atomization
Documentation and IPQA
• Regulatory affairs
ROLE & RESPONSIBILITIES
At DR.REDDY’S Laboratories Ltd.
• Assistant manager- QA
• Coordinating IPQA team ,and prepare team for ALL TIME AUDIT READY NESS.
• White belt holder in Six sigma.
• Preparation and review of Standard operating procedures (SOPs).
• Investigation of Incidents and its root cause identification, and review of incidents in
production and packing.
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3. • Investigations through SAP transactions like QM02,QM03,iqs22,QA32 and QA33.
• Review of cGMP issues in Production.
• Responsible for atomization of equipments and process, and review of equipment printouts
and troubleshooting activities.
• Responsible for CRASA (Card reading access systems approach) effectiveness.
• Review of QMS Documents - Change controls, Temporary changes, OOS ,OOT’s and CAPA.
• Investigation of market complaints.
• Handling of Regulatory Audits ,Customer Audits and is complains.
• Preparation and review of batch processing records.
• Execution of process validation and review protocols and reports.
• Execution of cleaning validation and review of protocols and reports.
• Preparation and review of APR’s.
• Reporting to Manager-QA.
KNOLEDGE ABOUT.: 21 CFR 210,211 Guidelines, WHO Guidelines, Qbd approach and SAP
transactions.
At Natco Pharma Ltd.
As a Audit & compliance –Officer -QA
• Preparation and review of Standard operating procedures (SOPs).
• Investigation of market complaints.
• Handling of audits.
• Regulatory and audit compliance.
• Handling of Technical / Quality Agreements.
• Handling of Mock/Product Recalls.
• Self Inspection Programmer
• Review of QMS Documents - Change controls, Incidents, Temporary changes,
OOS and CAPA.
• Filling Vendor questionnaires and providing the Technical support to the Customers.
• Preparation and Review of Errata and Ratifications
• Preparation and Review of APR’s.
As a IPQA
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4. • Performing In-process Quality assurance functions as per procedures.
• Monitoring compliance of BPR during production and packing.
• Monitoring of in-process bulk, finished products and retention samples and stability samples.
• Sampling of swab/rinse samples for cleaning validation.
• Sampling of validation samples.
• Preparation of process validation and cleaning validation and hold time study protocols and
reports.
• Review of batch processing records.
• In-process UD’s and final batch release in SAP.
• Reporting any deviation during process and packing to Head-QA/Dy.Manager-QA.
• Monitoring, storage, handling and retrieval of control samples and documents.
• Preparation of Batch processing records.
• Compilation of data and preparation of annual product review.
• Verification of Dispatch labels, Packing List, Dispatch COA’S and Delivery challans as per
the Dispatch Schedule.
• Reporting to Dy. Manager.
At Lee Pharma Ltd.
• Officer- QA
• Preparation of Cleaning Validation Protocol’s.
• Execution of Cleaning Validation.
• Handling of Change Controls and Deviations.
• Preparation of Process Validation Protocol’s.
• Execution of Process Validation.
• Handling of Customer complaints.
• Preparation of Annual product review.
• Preparation of training Schedules.
• Review & maintaining the cGMP, GMP and GLP Records in Production and lab premises.
• Sampling of Inprocess, Finished and Commercial Product.
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5. • Preparation and Review of BMR’S & BPR’S.
• Preparation and Review of Standard Operating Procedures.
• Line clearance for Dispensing, Inprocess, Blending activities.
• Verification of Dispensing Activity.
• Verification of Dispatch labels, Packing List, Dispatch COA’S and Delivery challans as per
the Dispatch Schedule.
• Ensuring Compliance during various manufacturing stages.
• Reporting to assistant manager.
ABOUT THE ORGANISATION’S
About DR.REDDY’S Laboratories Ltd.:
The organization “DR.REDDY’S Laboratories Ltd.” is US-FDA , MHRA,TPD Canada, Minsitry
of Health Greece, Infarmed Portugal, ANIVISA, German Health Authority Hamburg and ISO 9001:
2008 , Certified company and it is pioneer in manufacturing of Pharmaceutical formulations for
reputed multinational companies like GSK. SA 8000 certified company.The facilities are
continuously upgraded as per the requirement of principals and have undergone Several
International Audits and have been rated as one of them best in the business.
About NATCO PHARMA:
The organization “Natco Pharma Ltd” is US-FDA , TPD Canada, Minsitry of Health Greece,
Infarmed Portugal, ANIVISA, German Health Authority Hamburg and ISO 9001: 2008 , Certified
company and it is pioneer in manufacturing of Pharmaceutical formulations for reputed
multinational companies like Actavis (Watson), Breckenridge, Ascend, Heumann, Synthon,
Marcan, Jamp, Mint Lupin (Jenson group) and Pack Pharma. Reputed Indian Companies like
Dr.Reddy’s, Ranbaxy and GSK. The company successfully launched Lansoprazole DR Capsules 15
& 30mg and Rizatriptan benzoate tablets 5 & 10mg in to US market in December2012 and
Rizatriptan OD tablets 5 and 10mg in June -2013.
About LEE PHARMA:
The organization “LEE Pharma Ltd” is ISO 9001: 2008 , WHO GMP And EUROPIAN GMP
Certified company and it is pioneer in manufacturing of Pharmaceutical formulations for reputed
multinational companies like DVA, Dexcel pharma, Abott and Stock pharma ltd Reputed Indian
Companies like Ajantha pharma Pvt Ltd, Unichem, Micro labs.
AUDIT EXPERIENCE
At DR.REDDY’S Laboratories:.
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6. • Successfully faced USFDA,MHRA,ANIVISA,EU-GMP audits, and played active role in
customer audits like GSK and Du-Pont laboratories.
At Natco Pharma Ltd.:
• Successfully faced German Audit (BGV-Hamburg) and ANIVISA(Agência Nacional de
Vigilância Sanitária (National Health Surveillance Agency Brazil) ).
• Played Active Part in facing Breckenridge, Actavis, Lupin (Jenson group), GSK, Ranbaxy,
MSN and Dr. Reddy’s Customer Audits.
At Lee Pharma Ltd
• Successfully faced EU GMP and WHO Audits.
• Played active part in facing Remedica, Slavia, Torrent, Dexcel and Unichem Customer
Audits.
INDUSTRIAL EXPERIENCE/ TRAINING
• 8 months Project-training at Matrix Laboratories Limited, Hyderabad, Andhra Pradesh
from July 2010 to Feb-2011.
EDUCATIONAL QUALIFICATION
Degree Institution Year
Board /
University
Percentage
M.Pharm
(Pharmaceutics)
SRM college of pharmacy,
Kattankulatur, Kancheepuram,
Tamilanadu.
2011
SRM
university
8.059(CGPA)
B. Pharmacy
Hindu college of pharmacy,
Guntur, A.P.
2009
Nagarjuna
university
69.77%
Intermediate S.S.P Junior college, Guntur-A.P 2005 BIE 73.5%
S.S.C.
Z.P. High School,
Nambur,Guntur-A.P.
2003 BSE 61.6%
TECHNICAL SKILLS
• Handling and Operation of Nanomill, fluid bed processer(G.P.C.G 1.1), Rapid mixer granulator,
Roll compactor, Air jet mill, extruder and spheronizer, High pressure homogenizer, Zetasizer
nano series, Compression and Coating machine.
• Handling of Dissolution Apparatus (Electro lab), Differential scanning calorimeter, UV-
Spectrophotometer.
PROJECT WORK
M.Pharm.:
• Enhancement of Solubility of Poorly Water Soluble Drug through Nanotechnology at Matrix
Laboratories Limited, Hyderabad, Andhra Pradesh from July 2010 to Feb-2011.
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7. HOBBIES
• Listening to music.
• Playing cricket.
• Reading books.
• Traveling
STRENGTHS
• Flexible quick learner and good listener.
• Self confident and imaginative.
• Willingness to accept challenges which can encourage my skills and knowledge.
• Dedicated with Positive Mental Attitude as well as good Communication and interpersonal
Skills.
PERSONAL DETAILS:
Name : Satish Reddy Mandala
Father’s Name : Veera Reddy Mandala.
Date of Birth : 16th
March 1988.
Languages Known : English, Telugu and Hindi
Marital Status : Bachelor.
Address : H.No:9-52, Old Vysa Bank
Nambur,Pedakakani(M.D)
Guntur -522508.
DECLARATION:
I hereby declare that the information furnished above is true to the best of my knowledge.
Place : Hyderabad
Date :
(SATISH REDDY MANDALA)
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