SlideShare a Scribd company logo
1 of 4
CURRICULUMVITAE
G. RAMANJANEYULU
C/o S.K.Haroom,
H.No:17-59/21, Plot No: 91,
Ramnagar colony, Alwal
Secendrabad-500010. Mobile No: +91 8886534747,+91 8886534848
India Email: ramanjaneyulu10_g@yahoo.co.in.
Objective:
To associate myself with an organization where there is an opportunity to carve up,
contribute, perk up my knowledge and work as a team toward the success of the
organization.
Experience Summary : 11 years 3months of Experience in Pharmaceutical analysis
and documentation (Formulation).
AUDITS FACED
US FDA, MHRA, TGA, WHO, CANADA and POLAND.
EDUCATIONAL QUALIFICATIONS:
1 M.Sc.,(Analytical Chemistry) from SRTM University, Nanded (2003-2005)
2 B.Sc., (Maths, Physics and Chemistry) NagarjunaUniversity.
Current Employer: Novartis Health Care LTD,
R&D Hyderabad.
Duration: From Dec-2012 To Till date.
Previous Employer: Micro Labs Ltd,
Quality Control (Corporate Analytical Department).
Unit I ,II& III, Formulation Units Hosur,
Duration: From April 2011 To Dec-2012.
Previous Employer: Aurobindo Pharma Limited,
(Formulation Unit-III) Stability Department,
Hyderabad.
Duration: From July 2007 to April 2011.
Previous Employer: NATCO Pharma Limited,
(Formulation Unit -1V) Hyderabad
Chemist in Quality Control Department
(June2005 to July 2007)
Present Experience:
Working as a Senior Scientist in ARD India in Novartis Health Care LTD, Hyderabad.
 Executed the end to end responsibility of various project with Registration,
clinical and technical stability projects.
 Meet quality, quantity and timelines in all assigned projects of Method Validation
and Clinical stability
 Various kind of Documentation done in TEDI data base (Technical
documentation information system) for example preparation of SOP’s,
Analytical methods, specifications, Stability reports (DSR), validation protocols
and reports, validation summaries etc.
 Review and approval of Clinical Stability analysis Reports for its correctness,
completeness and trending of stability data.
 Review and approval of release, retest (Clinical) batches for various projects
 Involving in the OOS/OOT /Deviation investigation and its documentation and
reporting with respect to cGMP norms.
 Responsible for frequent Auditing of Analytical Department as per self-
inspection plan and also to ensure compliance against previous audit
observations.
 Understanding of Laboratory information management system, to perform the
various operations.
 Expert in OOS/OOE/OOT data management system with AQWA(Analytical
quality work flow)-application
 Review and approval of Qualification document of various analytical instruments
and equipment’s .
Previous Experience:
Worked with Micro labs LTD Unit-I,II&III Hosur Quality control (Analytical Review
Team) as a Reviewer.
 Review of all the Analytical reports of Raw material, finished product for its
correctness &compliance to the system before they are being released for use and
distribution.
 Review of Stability analysis Reports for its correctness and trend analysis.
 Reviewing and approval the calibration Reports of all Analytical instruments.
 Reviewing of master Analytical work records for its correctness.
 Reviewing and updation the Raw material and Finished Product STP’s, inline
with Pharmacopieal monograph.
 Updation of General testing procedures in line with Pharmacopieal general
chapters.
 As part of AQA, Participating in the OOS/OOT/Deviation investigation and its
proper documentation and reporting.
 Actively involved in Internal &Regulatory Audits.
Previous Experience:
Worked as a Executive, Quality Control, Stability studies at AUROBINDO PHARMA
LTD, Unit–III, Formulation division, Hyderabad. (July2007 to April 2011).
Job responsibilities:
 Analysis of Stability Samples.
 Calibration of Analytical Instruments.
 Analysis of Stability samples for commercialized & exhibit batches for various
regulatory markets, as per ICH Guidelines
 Investigation of OOS/ OOT and Incidents.
 Monitoring stability Chambers
 Preparation & review of Worksheets.
 Review and approval of Analytical reports.
 Compilation & Submission of Stability data.
 Reporting and Review of data in Laboratory Information
Management System (LIMS).
Previous Experience:
Worked in NATCO PHARMA LTD, Hyderabad (Formulation unit 1V-USFDA
Approved Plant) as a Chemist in Quality Control Department (June2005toJuly 2007)
Job responsibilities:
 Finished Product and stability samples Analysis
 Maintaining documents as per cGMP requirement.
 Troubleshooting and maintenance of various analytical instruments
 Hands on experience in the operation and calibration of analytical instruments.
 Reviewing stability studies protocols and records.
 Indenting of chemicals / columns / glassware / spares / other operational supplies.
 Handling of various instruments like i.e., HPLC, UV Spectro photometer, IR
Apparatus Autotitrator. KF apparatus, Friability apparatus, Dissolution,
Disintegration, etc.
Personal profile:
Name : G. Ramanjaneyulu
Koniki post, Inkollu mandal
Prakasam District ,Andhra Pradesh
India, PIN :523167
Date of Birth : 10th June 1980
Languages Known : English, Hindi and Telugu.
Declaration:
I hereby declare that the above-furnished information is correct as per the best of
my knowledge and I bear the responsibility for the correctness of those above-mentioned
particulars.
(G. RAMANJANEYULU)

More Related Content

What's hot

Resume Sravani M.Sc Integrated pharmaceutical chemistry (1) (1) (1) (1)
Resume Sravani M.Sc Integrated pharmaceutical chemistry (1) (1) (1) (1)Resume Sravani M.Sc Integrated pharmaceutical chemistry (1) (1) (1) (1)
Resume Sravani M.Sc Integrated pharmaceutical chemistry (1) (1) (1) (1)Sravani Vallapureddy
 
Nabl 112 gap analysis general
Nabl 112 gap analysis generalNabl 112 gap analysis general
Nabl 112 gap analysis generaljdyjdo
 
Laboratory and Pharmaceutical Quality Assurance Expert
Laboratory and Pharmaceutical Quality Assurance ExpertLaboratory and Pharmaceutical Quality Assurance Expert
Laboratory and Pharmaceutical Quality Assurance ExpertMathias Atelefack
 
Good Laboratory Practices ppt
Good Laboratory Practices pptGood Laboratory Practices ppt
Good Laboratory Practices pptKrushna Yadav D K
 
Pharmacovigilance role through investigating Out of Specification (OOS) for F...
Pharmacovigilance role through investigating Out of Specification (OOS) for F...Pharmacovigilance role through investigating Out of Specification (OOS) for F...
Pharmacovigilance role through investigating Out of Specification (OOS) for F...Mohamed Raouf
 
Are we using the correct quality goals?
Are we using the correct quality goals?Are we using the correct quality goals?
Are we using the correct quality goals?Ola Elgaddar
 
Deviation, OOS & complaint investigation and CAPA
Deviation, OOS & complaint investigation and CAPADeviation, OOS & complaint investigation and CAPA
Deviation, OOS & complaint investigation and CAPADr. Amsavel A
 
2016 LabHIT LRI EHR Test Methods for CLIA Compliance
2016 LabHIT LRI EHR Test Methods for CLIA Compliance2016 LabHIT LRI EHR Test Methods for CLIA Compliance
2016 LabHIT LRI EHR Test Methods for CLIA ComplianceMegan Sawchuk
 
Sampling in process validation
Sampling in process validationSampling in process validation
Sampling in process validationSalum Mkata
 
Jill Woods Resume 20150401
Jill Woods Resume 20150401Jill Woods Resume 20150401
Jill Woods Resume 20150401Jill Woods
 
Investigation of OOS and OOT results
Investigation of OOS and OOT resultsInvestigation of OOS and OOT results
Investigation of OOS and OOT resultsMoshfiqur Rahaman
 
Manager-quality control
 Manager-quality control Manager-quality control
Manager-quality controlNarender Adepu
 

What's hot (20)

Good lab practices (GLP)
Good lab practices (GLP)Good lab practices (GLP)
Good lab practices (GLP)
 
Resume Sravani M.Sc Integrated pharmaceutical chemistry (1) (1) (1) (1)
Resume Sravani M.Sc Integrated pharmaceutical chemistry (1) (1) (1) (1)Resume Sravani M.Sc Integrated pharmaceutical chemistry (1) (1) (1) (1)
Resume Sravani M.Sc Integrated pharmaceutical chemistry (1) (1) (1) (1)
 
Nabl 112 gap analysis general
Nabl 112 gap analysis generalNabl 112 gap analysis general
Nabl 112 gap analysis general
 
Quality and Regulatory Affairs
Quality and Regulatory AffairsQuality and Regulatory Affairs
Quality and Regulatory Affairs
 
Laboratory and Pharmaceutical Quality Assurance Expert
Laboratory and Pharmaceutical Quality Assurance ExpertLaboratory and Pharmaceutical Quality Assurance Expert
Laboratory and Pharmaceutical Quality Assurance Expert
 
1. validation
1. validation1. validation
1. validation
 
Good Laboratory Practices ppt
Good Laboratory Practices pptGood Laboratory Practices ppt
Good Laboratory Practices ppt
 
Pharmacovigilance role through investigating Out of Specification (OOS) for F...
Pharmacovigilance role through investigating Out of Specification (OOS) for F...Pharmacovigilance role through investigating Out of Specification (OOS) for F...
Pharmacovigilance role through investigating Out of Specification (OOS) for F...
 
Are we using the correct quality goals?
Are we using the correct quality goals?Are we using the correct quality goals?
Are we using the correct quality goals?
 
Deviation, OOS & complaint investigation and CAPA
Deviation, OOS & complaint investigation and CAPADeviation, OOS & complaint investigation and CAPA
Deviation, OOS & complaint investigation and CAPA
 
2016 LabHIT LRI EHR Test Methods for CLIA Compliance
2016 LabHIT LRI EHR Test Methods for CLIA Compliance2016 LabHIT LRI EHR Test Methods for CLIA Compliance
2016 LabHIT LRI EHR Test Methods for CLIA Compliance
 
NEW_RESUME
NEW_RESUMENEW_RESUME
NEW_RESUME
 
Sampling in process validation
Sampling in process validationSampling in process validation
Sampling in process validation
 
KC
KCKC
KC
 
Jill Woods Resume 20150401
Jill Woods Resume 20150401Jill Woods Resume 20150401
Jill Woods Resume 20150401
 
Investigation of OOS and OOT results
Investigation of OOS and OOT resultsInvestigation of OOS and OOT results
Investigation of OOS and OOT results
 
RESUME_JP_new
RESUME_JP_newRESUME_JP_new
RESUME_JP_new
 
Manager-quality control
 Manager-quality control Manager-quality control
Manager-quality control
 
40718
4071840718
40718
 
Quality Control for Medical Laboratories
Quality Control for Medical LaboratoriesQuality Control for Medical Laboratories
Quality Control for Medical Laboratories
 

Similar to Gudi Ramanjaneyulu (20)

Mallikarjuna rao resume dqa
Mallikarjuna rao resume dqaMallikarjuna rao resume dqa
Mallikarjuna rao resume dqa
 
Ghazala Rahim (1)
Ghazala Rahim (1)Ghazala Rahim (1)
Ghazala Rahim (1)
 
CV_Tanveer Ahmed - 31-07-2016
CV_Tanveer Ahmed - 31-07-2016CV_Tanveer Ahmed - 31-07-2016
CV_Tanveer Ahmed - 31-07-2016
 
Kamal_Jeet_Singh_Resume_QA_RB
Kamal_Jeet_Singh_Resume_QA_RBKamal_Jeet_Singh_Resume_QA_RB
Kamal_Jeet_Singh_Resume_QA_RB
 
CV_AN
CV_ANCV_AN
CV_AN
 
CV_AN
CV_ANCV_AN
CV_AN
 
thiru_30_may_16
thiru_30_may_16thiru_30_may_16
thiru_30_may_16
 
CVQC_SP
CVQC_SPCVQC_SP
CVQC_SP
 
Resume
Resume Resume
Resume
 
Resume _Dr.Raman Deep Singh
Resume _Dr.Raman Deep SinghResume _Dr.Raman Deep Singh
Resume _Dr.Raman Deep Singh
 
CV-SAN
CV-SANCV-SAN
CV-SAN
 
Curriculum Vitae
Curriculum VitaeCurriculum Vitae
Curriculum Vitae
 
RKS Resume July,2016(PQC D )
RKS Resume July,2016(PQC D )RKS Resume July,2016(PQC D )
RKS Resume July,2016(PQC D )
 
MEHUL PATEL_ JUNE
MEHUL PATEL_ JUNEMEHUL PATEL_ JUNE
MEHUL PATEL_ JUNE
 
K M Suleman
K M SulemanK M Suleman
K M Suleman
 
Vipul Patel
Vipul PatelVipul Patel
Vipul Patel
 
Resume-vipul patel
Resume-vipul patel Resume-vipul patel
Resume-vipul patel
 
Hassan Haider Siddiqui CV.pdf
Hassan Haider Siddiqui CV.pdfHassan Haider Siddiqui CV.pdf
Hassan Haider Siddiqui CV.pdf
 
AK resume.doc
AK resume.docAK resume.doc
AK resume.doc
 
NEW_RESUME
NEW_RESUMENEW_RESUME
NEW_RESUME
 

Gudi Ramanjaneyulu

  • 1. CURRICULUMVITAE G. RAMANJANEYULU C/o S.K.Haroom, H.No:17-59/21, Plot No: 91, Ramnagar colony, Alwal Secendrabad-500010. Mobile No: +91 8886534747,+91 8886534848 India Email: ramanjaneyulu10_g@yahoo.co.in. Objective: To associate myself with an organization where there is an opportunity to carve up, contribute, perk up my knowledge and work as a team toward the success of the organization. Experience Summary : 11 years 3months of Experience in Pharmaceutical analysis and documentation (Formulation). AUDITS FACED US FDA, MHRA, TGA, WHO, CANADA and POLAND. EDUCATIONAL QUALIFICATIONS: 1 M.Sc.,(Analytical Chemistry) from SRTM University, Nanded (2003-2005) 2 B.Sc., (Maths, Physics and Chemistry) NagarjunaUniversity. Current Employer: Novartis Health Care LTD, R&D Hyderabad. Duration: From Dec-2012 To Till date. Previous Employer: Micro Labs Ltd, Quality Control (Corporate Analytical Department). Unit I ,II& III, Formulation Units Hosur, Duration: From April 2011 To Dec-2012. Previous Employer: Aurobindo Pharma Limited, (Formulation Unit-III) Stability Department, Hyderabad. Duration: From July 2007 to April 2011. Previous Employer: NATCO Pharma Limited, (Formulation Unit -1V) Hyderabad Chemist in Quality Control Department (June2005 to July 2007)
  • 2. Present Experience: Working as a Senior Scientist in ARD India in Novartis Health Care LTD, Hyderabad.  Executed the end to end responsibility of various project with Registration, clinical and technical stability projects.  Meet quality, quantity and timelines in all assigned projects of Method Validation and Clinical stability  Various kind of Documentation done in TEDI data base (Technical documentation information system) for example preparation of SOP’s, Analytical methods, specifications, Stability reports (DSR), validation protocols and reports, validation summaries etc.  Review and approval of Clinical Stability analysis Reports for its correctness, completeness and trending of stability data.  Review and approval of release, retest (Clinical) batches for various projects  Involving in the OOS/OOT /Deviation investigation and its documentation and reporting with respect to cGMP norms.  Responsible for frequent Auditing of Analytical Department as per self- inspection plan and also to ensure compliance against previous audit observations.  Understanding of Laboratory information management system, to perform the various operations.  Expert in OOS/OOE/OOT data management system with AQWA(Analytical quality work flow)-application  Review and approval of Qualification document of various analytical instruments and equipment’s .
  • 3. Previous Experience: Worked with Micro labs LTD Unit-I,II&III Hosur Quality control (Analytical Review Team) as a Reviewer.  Review of all the Analytical reports of Raw material, finished product for its correctness &compliance to the system before they are being released for use and distribution.  Review of Stability analysis Reports for its correctness and trend analysis.  Reviewing and approval the calibration Reports of all Analytical instruments.  Reviewing of master Analytical work records for its correctness.  Reviewing and updation the Raw material and Finished Product STP’s, inline with Pharmacopieal monograph.  Updation of General testing procedures in line with Pharmacopieal general chapters.  As part of AQA, Participating in the OOS/OOT/Deviation investigation and its proper documentation and reporting.  Actively involved in Internal &Regulatory Audits. Previous Experience: Worked as a Executive, Quality Control, Stability studies at AUROBINDO PHARMA LTD, Unit–III, Formulation division, Hyderabad. (July2007 to April 2011). Job responsibilities:  Analysis of Stability Samples.  Calibration of Analytical Instruments.  Analysis of Stability samples for commercialized & exhibit batches for various regulatory markets, as per ICH Guidelines  Investigation of OOS/ OOT and Incidents.  Monitoring stability Chambers  Preparation & review of Worksheets.  Review and approval of Analytical reports.  Compilation & Submission of Stability data.  Reporting and Review of data in Laboratory Information Management System (LIMS).
  • 4. Previous Experience: Worked in NATCO PHARMA LTD, Hyderabad (Formulation unit 1V-USFDA Approved Plant) as a Chemist in Quality Control Department (June2005toJuly 2007) Job responsibilities:  Finished Product and stability samples Analysis  Maintaining documents as per cGMP requirement.  Troubleshooting and maintenance of various analytical instruments  Hands on experience in the operation and calibration of analytical instruments.  Reviewing stability studies protocols and records.  Indenting of chemicals / columns / glassware / spares / other operational supplies.  Handling of various instruments like i.e., HPLC, UV Spectro photometer, IR Apparatus Autotitrator. KF apparatus, Friability apparatus, Dissolution, Disintegration, etc. Personal profile: Name : G. Ramanjaneyulu Koniki post, Inkollu mandal Prakasam District ,Andhra Pradesh India, PIN :523167 Date of Birth : 10th June 1980 Languages Known : English, Hindi and Telugu. Declaration: I hereby declare that the above-furnished information is correct as per the best of my knowledge and I bear the responsibility for the correctness of those above-mentioned particulars. (G. RAMANJANEYULU)