1. SATYANARAYANA
QUALITY ASSURANCE Mobile: +91- 9502163050
mohansatyap@gmail.com +91- 8143912045
SUMMARY
Accomplished QA professional with 10 years of progressive experience and proven record of significant,
successful contribution in quality management, project management, process improvement, business analysis/
evaluation, product-development life cycle methodologies, supplier management, and quality-management
systems, processes, standards, and systems in a wide range of organizations that previously had no standards
or programs in place
CIRTIFICATES
Participated in four days training programme “INTERNAL AUDITOR TRAINING PROGRAM”
based on ISO 9001:2000 AND ISO/IEC 17025:2005 conducted at Magene life sciences from 3rd
dec
-6th
dec2007.
Participated in four days training programme on “LABORATORY QUALITY MANAGEMENT &
INTERNAL AUDIT” as per ISO 15189:2007 conducted by CETE from 28th
sep- 1st
Oct 2011.
Participated in four days training programme “ADVANCED KEY OPERATORS TRAINING
PROGRAMME” held at Ortho Clinical Diagnosics from 20 – 23 June, 2012
ACADEMIC QUALIFICATION :
M.Sc, Biotechnology 2004 from Nagarjuna University with 1st
Div (62%)
B.Sc, Life Sciences 2002 from Nagarjuna University with 2nd
Div (56%)
XIIth
Class 1998 from National Open School with 2nd
Div (54%)
PATHCARELABS 30th
SEP. 2013 – JULY.2014
Asst. Manager-QA, PATHCARELABS, chiryala, Distt. : Ranga Reddy , Telangana State, India
JOB RESPONSIBILITIES AS ASST. MANAGER-:
(a) Provide hands on training to the new recruits. Ensuring all testing procedures are conducted as
per defined sop. Ensuring testing is conducted as per the specified turn around time. Ensuring
accuracy & correctness of results by strict compliance to defined sop, calibration, quality control,
procedure & training of personnel. Ensure STAT (urgent) reporting. Ensure efficiency of testing by
proper planning & optimum utilization of supplies, equipment, work allocation & supervision of
all operations conducted in the section. Initiating improvements in existing SOP. Ensure optimum
utilization of manpower, equipment, reagents & time. Stock management of procured material
from store. Ensuring the space, equipment & other ancillary equipment are maintained in
optimum working condition & managing critical situation like equipment break down, staff
shortage, reagent shortage, Unavailability or sudden heavy workload. Maintenance of records.
(c) Preparation for compliance of concerned Statutory and Regulatory requirements
(d) Responsible for all aspects of the Quality System for the laboratory under the guidance of the
Director Lab operations. Review and update the Quality Manual. Monitor laboratory practices to
verify continuing compliance with policies and procedures. Evaluate instrument calibration and
maintenance records. Ensure the validation of new technical procedures. Investigate technical
problems, propose remedial actions, and verify their implementation. Propose corrections and
improvements in the quality system
(e) Responsibilities include development of method validation documentation. A recognized industry
leader specializing in GLP compliance and validation, including conducting GLP audits, providing
regulatory compliance training, compliance and validation results. Preparation of MRM, Planning
the internal Audits. Conducting In-house Calibration of Laboratory Equipment Preparing trend
analysis for Quality indicators. Assist in Internal and External Quality Systems Audits and the
CAPA implementation.
JOB RESPONSIBILITIES AS INTERNAL AUDITOR:
(a) Audit of Quality Management System as per ISO 15189:2007, NABL & CAP
(b) Business development for above Management system
2. KIMS HOSPITALS 2010 - 2013
Quality Manager-KIMS Hospitals, Siddhartha Nagar, Pinamaneni poly clinic, Distt. : Krishna,
Andhra Pradesh, India
1. Method validation studies, method comparison studies and integrity studies. Monitoring IQC
and EQAS performance in the departments and taking corrective action for outliers.
2. Document management, identification of internal training needs and assistance for
implementation of training programs, periodic review of personnel files, assistance for vendor
selection and performance monitoring.
3. Planning internal audit schedule and collection center audit schedule to identify the staff
training needs and ensure that appropriate training (Initial and Periodic) are carried out for
Quality Assurance staff and all other technical staff working at the Unit. Preparing Standard
Operating Procedures (SOP).
4. Ensure compliance with CLIA requirements and laboratory procedures, including
maintenance of laboratory equipment, resolving complex clinical instrument problems.
5. Evaluated quality control within the laboratory using standard lab test and measurement
controls.
6. Handled the gamut of activities encompassing Bioassays, Fully Automated Biochemistry
analyzers (vitros350,) cell counters (Beckmen coulter HMX, Sysmax I 1800) Hormonal
analyzer Beckmen coulter Asscess2 and semi automated chem-7, Easylyte , Radiometer ABG,
CA-50. Perform complex laboratory tests and procedures on blood and other body fluids,
according to laboratory policies. Conducting In-house Calibration of Laboratory Equipment.
MAGENE LIFESCIENCES PVT LTD 2007 - 2010
Working on down stream process of therapeutic proteins (interlukin-2 and antimycin).
Laboratory testing of protocol changes in Downstream processes prior to scaling up to pilot plant.
Method development on Äkta Explorer system.
Purification of specific secondary metabolites. Sample preparation and size exclusion
chromatography.
Culture cultivation of fungal culture cultivation and E.coli on laboratory media.
Protein purification Techniques: Protein purification by Ion exchange chromatography (IEC),
Gel filtration chromatography or Size exclusion chromatography (SEC), Affinity chromatography
(AC) using AKTA prime, AKTA Explorer platforms.
Protein Characterization Techniques:
Characterization of proteins by Bradford and Lowry methods, SDS-PAGE analysis, Iso Electric
Focusing (IEF), Western Blotting, and silver staining.
Molecular & Immuno Techniques:
Isolation of DNA and RNA, Agarose Gel Electrophoresis, PCR, cloning, restriction digestion, Gel
Imaging System (UVP), Shaker incubators, DNA Electrophoresis system (Bio-Rad), UV-Vis
Spectrophotometer, Gel dryer (Amersham Biosciences).
1Southern/Northern blot chamber (Amersham Biosciences) Western transfer apparatus
(Amersham Biosciences) Refrigerated centrifuges (Beckman Coulter) Protein Electrophoresis (Bio-
Rad).
Fermentation techniques:
Flask level fermentation techniques, TLC, Quantification of unknown sample by fluorescence.
THYROCARE TECHNOLOGIES Ltd., MUMBAI 2005 to 2007
Key Deliverables across the tenure
Handled the gamut of activities encompassing Bioassays, Biochemistry analyzers, ELISA & CLIA,
western blotting. Conducted analysis of thyroid hormones, tumor markers, Precision studies, and
statistics studies of viral diseases, hormones analysis, and serum samples. Ensuring complete in-
process quality control and continuous improvement in process capabilities. Conducting Routine
maintenance, calibration and troubleshooting for analytical equipment on a regular basis for
higher productivity and efficiency. Foreseeing performance bottlenecks and taking corrective
measures to avoid the same.
Documentation/Quality Compliance.
Ensuring compliance of various quality measures by maintenance of appropriate requisite
documentation/ records. Imparting training to all employees, pertaining to quality
3. implementation and compliance. Participating in ISO Certification, NABL, CAP ,Surveillance and
recertification audits.
PROJECTS IN MY MASTER’S
Title: Isolation of DNA from (Bacillus Thuringensis) BT Cotton Seed and Qualitative Estimation of
BT Toxin, National Institute of Nutrition.
Duration : Three months (May’03 to July’ 03)
Guide : Dr. Remash V. Bhat (Food and Drug toxicology)
Title: Exposure to various Fermentation Processes – Quality Control of Diphtheria, Pertusis,
Tetanus & Rabies, Group of Vaccines at Pasteur Institute of India, Coonoor, Nilgiris. One month
(Jan’03)
Title: Exposure to various Mammalian Cell Culture Techniques at Sri Raghavendra
Biotechnologies Private Limited, Bangalore.
Duration : One month (Feb’03)
Guide : Dr. S.G.A. Rao
Title: Exposure to various Molecular Biology Techniques like HPLC, FPLC, Flow-Cytometry, SDS-
PAGE, Protein, Sequencing, PCR, RT- PCR and DNA Sequencing. Post Graduate of Medical
Education & Research Center, Chandigarh-160012
Duration : 45 days (June 1st
to July 15).
Guide : Dr.S. Majumdar.
:
MANAGERIAL SKILS
Ability to work independently with minimal supervision and attain group goals Strong
organizational and interpersonal skills, including the ability to prioritize workload Possesses the
ability to deal effectively with a variety of personnel and executive leadership Manage and mentor
teams to achieve organization and individual goals.
HOBBIES:
Sports & Games, Reading Books, Gardening
Social Interaction
PERSONAL PROFILE :
Father’s Name : Satyanarayana.P
Sex : Male
Date of Birth : 09-April-1979
Matrial Status : Married
Language : Telugu, English, Hindi
E-mail id : mohansatyap@gmail.com
Permanent Address : sitharamanagar, door no 8-20-28/37, Guntur-1
Contact No. : 8143912045/9502163050
REFERENCES
1. Dr. B. Parvathi Devi
M.D. Microbiologist,
Director Lab Operations
PathcareLabs
Dr.parvathi@pathcarelabs.com
Ph: 9949998558
2. Dr. Desai Vidya Sripad,
M.D Biochemistry,
